Tooling for creating tapered opening in tissue and related methods

ABSTRACT

According to some embodiments, a tool for creating a wedge opening within a bone tissue is disclosed. The tool includes an outer member, a cutting member, and an inner member. The inner member moves within the inner passage of the cutting member where when the inner member is moved within the inner passage of the cutting member, the at least one cutter radially expands at an angle relative to a longitudinal axis of the tool.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 16/438,725, filed Jun. 12, 2019, which is a divisionalapplication of U.S. patent application Ser. No. 15/098,265, filed Apr.13, 2016, now U.S. Pat. No. 10,350,072 issued Jul. 16, 2019, whichclaims priority benefit of U.S. Provisional Application No. 62/147,548,filed Apr. 14, 2015, the contents of which are incorporated by referenceherein and made a part of the present application. In addition, U.S.patent application Ser. No. 13/480,272, filed on May 24, 2012 and issuedon Oct. 13, 2015 as U.S. Pat. No. 9,155,543, is hereby incorporated byreference herein in its entirety and made a part of the presentapplication.

BACKGROUND Field

This application relates generally to anatomical implants, and morespecifically, to hydrogel joint implants and various tools, devices,systems and methods related thereto.

Description of Related Art

Implants are often used to replace deteriorated or otherwise damagedcartilage within a joint. Such devices can be used to treatosteoarthritis, rheumatoid arthritis, other inflammatory diseases,generalized joint pain and/or other joint diseases. To ensure properfunction and long term effectiveness, such implants should be properlysecured within a patient's bone or other implant site.

SUMMARY

According to some embodiments, a tool for creating a wedge (e.g.,reverse tapered) opening within tissue comprises an outer membercomprising a distal end, the distal end comprising a tapered portionconfigured to be inserted within a cylinder-shaped opening createdwithin tissue, a cutting member coupled to the outer member, the cuttingmember comprising at least one cutter configured to be radiallyexpanded, and an inner member configured to be moved within an interiorof the cutting member when moved relative to the outer member, whereinradial expansion of the at least one cutter is configured to occur whenthe inner member is moved within the interior of the cutting member,wherein the at least one cutter is configured to be radially expanded atan angle relative to a longitudinal axis of the tool so as to create thewedge opening within tissue when the tool is expanded and rotatedrelative to said tissue.

According to some embodiments, the tool is configured to be rotatedmanually to create the wedge opening, wherein the at least one cuttercomprises a sloped inner surface, such that when the inner member isadvanced within an interior of the cutting member, the inner memberengages and urges the at least one cutter radially outwardly, andwherein the at least one cutter is configured to radially retract oncethe inner member is retracted from an interior of the cutting member.

According to some embodiments, the inner member is configured to engageand move relative to the outer member. In one embodiment, the innerportion comprises a threaded portion configured to engage acorresponding threaded portion of the outer member. In some embodiments,engagement of the inner portion relative to the outer member isconfigured to move the inner portion relative to the outer member, in alongitudinal or axial direction of the tool. In some embodiments, thetool is configured to be rotated manually to create the wedge opening.

According to some embodiments, the at least one cutter is resilientlybiased radially inwardly, and wherein advancement of the inner memberwithin an interior of the cutting member urges the at least one cutterradially outwardly. In some embodiments, the at least one cuttercomprises two cutters that are oriented opposite of each other. In someembodiments, the distal end of the outer member comprises a taperedportion sized, shaped and configured to fit within a cylindrical openingof tissue. In one embodiment, the tapered portion of the outer membercomprises a cylindrical shape.

According to some embodiments, the cutting member is secured to theouter member using a press-fit connection, another mechanical connectionand/or the like. In some embodiments, the outer member comprises a firstouter member portion and at least a second outer member portion, whereinthe first outer member portion is configured to couple and secure to thesecond outer member portion prior to use. In some arrangements, thefirst outer member portion is configured to couple to the second outermember portion using a threaded connection. In one embodiment, thecutting member is configured to be secured relative to the outer memberwhen the first outer member portion is coupled to the second outermember portion. In some configurations, the cutting member comprises atleast one protruding member, wherein the at least one protruding memberis configured to move within at least one corresponding slot of at leastone of the first outer member portion and the second outer memberportion when the first outer member portion is coupled to the secondouter member portion.

According to some embodiments, the tool is configured to be reusable. Inother embodiments, the tool is configured to be disposable. In someembodiments, the tool is at least partially reusable and at leastpartially disposable. In one embodiment, the tool is configured to besterilized between uses.

According to some embodiments, the at least one cutter comprises asloped inner surface, such that when the inner member is advanced withinan interior of the cutting member, the inner member engages and urgesthe at least one cutter radially outwardly. In some embodiments, the atleast one cutter is configured to radially retract once the inner memberis retracted from an interior of the cutting member.

According to some embodiments, the tool comprises a metallic material(e.g., stainless steel). In some embodiments, the tool comprises apolymeric material. In some embodiments, the tool is cannulated topermit the passage of a guide pin or other device through an axialopening through the tool.

According to some embodiments, a kit for treating tissue of a subjectcomprises a tool according to any embodiments disclosed herein, and animplant (e.g., hydrogel implant) configured to be inserted and securedwithin the wedge opening created by the tool. In some embodiments, thekit further comprise an introducer, wherein the introducer is configuredto deliver an implant within the wedge opening in an at least partiallycompressed and release the implant into an expanded shape, wherein theimplant, once implanted and in the expanded shape, is configured tosecurely remain within the wedge opening after implantation. In someembodiments, the kit further comprises a separate tool configured tocreate the cylinder-shaped opening. In some embodiments, the separatetool comprises a mechanically-operated tool comprising a drill bit. Insome arrangements, the kit further comprises a mechanically-assistedtool to help move the implant within the wedge opening.

According to some embodiments, a method of treating a joint of a patientcomprises creating a cylindrical recess in a bone located at or near atargeted joint, wherein the cylindrical recess comprises a surfaceopening along an outer surface of the bone, a bottom opening along thedistal end of the recess and side walls generally extending between thesurface opening and the bottom opening, wherein the side walls aregenerally perpendicular to the longitudinal axis of the cylindricalrecess, creating a wedge recess in the bone using a tool by removingadditional tissue from the side walls of the cylindrical recess,wherein, once the wedge recess is created, a diameter or othercross-sectional dimension of the bottom opening is larger than adiameter or other cross-sectional dimension of the surface opening,wherein the tool comprises a cutting portion, the cutting portioncomprising at least one cutter that is radially expanded by advancing aninner member within the cutting portion, wherein the wedge recess iscreated by manually rotating the tool so that the cutting portionrotates relative to the bone, at least partially withdrawing the innermember of the tool from the cutting portion to radially retract the atleast one cutter of the cutting portion, at least partially radiallycompressing an implant having a wedge shape, the implant comprising afirst end and a second end and body extending between the first end andthe second end, said second end being generally opposite of said firstend, wherein when the implant is in a radially uncompressed state, adiameter or other cross-sectional dimension of the first end is smallerthan a diameter or other cross-sectional dimension of the second end,while the implant is in a radially compressed state, inserting theimplant within the wedge recess, wherein the second end of the implantis inserted first within the wedge recess, wherein the second end of theimplant is adjacent the bottom opening of the wedge recess, and whereinthe first end of the implant is adjacent the surface opening of thewedge recess when the implant is properly positioned within the wedgerecess, and releasing the implant from a radially compressed state to aless compressed state, when the implant is properly positioned withinthe wedge recess, wherein, when the implant is in a less compressedstate, the diameter or other cross-sectional dimension of the second endof the implant is larger than the diameter or other cross-sectionaldimension of the surface opening of the wedge recess.

According to some embodiments, wherein, when the implant is in aradially uncompressed state, the body of the implant imparts a radialforce at least partially along the side walls of the wedge recess,thereby helping to secure the implant within the wedge recess, whereincreating a cylindrical recess comprises using a drill bit, wherein theat least one cutter is angled relative to a longitudinal axis of thetool when the at least one cutter is radially expanded, wherein the atleast one cutter comprises at least two cutters, and wherein the implantis radially compressed and inserted within the wedge recess using anintroducer.

According to some embodiments, wherein, when the implant is in aradially uncompressed state, the body of the implant imparts a radialforce at least partially along the side walls of the wedge recess,thereby helping to secure the implant within the wedge recess. In oneembodiment, creating a cylindrical recess comprises using a drill bit.In several arrangements, wherein the at least one cutter is angledrelative to a longitudinal axis of the tool when the at least one cutteris radially expanded. In some embodiments, the at least one cuttercomprises at least two cutters (e.g., 2, 3, 4, 5, more than 5 cutters,etc.).

According to some embodiments, the drill bit is cannulated, and whereinsaid drill bit is positioned over a guide pin to place a working end ofthe drill bit near a targeted location of the recess. In someembodiments, the implant is radially compressed and inserted within thewedge recess using an introducer. In one embodiment, an interior of theintroducer is tapered to radially compress an implant as the implant isadvanced through the introducer. In some arrangements, a distal end ofthe introducer is sized and configured to fit at least partially withinthe recess. In some embodiments, the implant is urged through aninterior of the introducer using a plunger or other pusher member. Inone embodiment, the implant is urged through an interior of theintroducer using a mechanically-assisted device. In one configuration,the mechanically-assisted device comprises a handle and a clamp coupledto said handle, wherein moving the clamp relative to the handle urges aplunger within an introducer to radially compress the joint implant andinsert the joint implant within the recess. In some embodiments, theclamp is rotatably coupled to the handle.

According to some embodiments, a ratio of the diameter or othercross-sectional dimension of the bottom opening of the wedge recess tothe diameter or other cross-sectional dimension of the surface openingof the wedge recess is approximately between 1.05 and 1.3. In oneembodiment, a ratio of the diameter or other cross-sectional dimensionof the bottom opening of the wedge recess to the diameter or othercross-sectional dimension of the surface opening of the wedge recess isat least 1.1. In some embodiments, the diameter or other cross-sectionaldimension of the bottom opening of the wedge recess is approximately 5%to 25% larger than the diameter or other cross-sectional dimension ofthe surface opening of the wedge recess. In some embodiments, the toolis cannulated such that the tool is delivered to a targeted anatomicalsite over a guide pin.

According to some embodiments, a method of treating a joint of a patientcomprises creating a cylindrical recess in a bone located at or near atargeted joint, wherein the cylindrical recess comprises a surfaceopening along an outer surface of the bone, a bottom opening along thedistal end of the recess and side walls generally extending between thesurface opening and the bottom opening, wherein the side walls aregenerally perpendicular to the longitudinal axis of the cylindricalrecess, creating a wedge recess in a bone using a tool by removingadditional tissue from the side walls of the cylindrical recess,wherein, once the reverse tapered recess is created, a diameter or othercross-sectional dimension of the bottom opening is larger than adiameter or other cross-sectional dimension of the surface opening,wherein the tool comprises a cutting portion, the cutting portioncomprising at least one cutter that is radially expanded by advancing aninner member within an outer member of the tool, wherein the reversetapered recess is created by rotating the tool, removing the tool fromthe recess after at least partially withdrawing the inner member of thetool from the outer member in order to radially retract the at least onecutter, at least partially radially compressing an implant having awedge shape, the implant comprising a first end and a second end andbody extending between the first end and the second end, said second endbeing generally opposite of said first end, wherein when the implant isin a radially uncompressed state, a diameter or other cross-sectionaldimension of the first end is smaller than a diameter or othercross-sectional dimension of the second end, while the implant is in aradially compressed state, inserting the implant within the wedgerecess, wherein the second end of the implant is inserted first withinthe wedge recess, wherein the second end of the implant is adjacent thebottom opening of the wedge recess, and wherein the first end of theimplant is adjacent the surface opening of the wedge recess when theimplant is properly positioned within the wedge recess, and releasingthe implant from a radially compressed state to a less compressed state,when the implant is properly positioned within the wedge recess;

wherein, when the implant is in a less compressed state, the diameter orother cross-sectional dimension of the second end of the implant islarger than the diameter or other cross-sectional dimension of thesurface opening of the wedge recess, wherein, when the implant is in aradially uncompressed state, the body of the implant imparts a radialforce at least partially along the side walls of the wedge recess,thereby securing the implant within the wedge recess.

According to some embodiments, creating a cylindrical recess comprisesusing a drill bit. In some embodiments, the at least one cutter isangled relative to a longitudinal axis of the tool when radiallyexpanded. In one embodiment, creating a wedge recess comprises manuallyrotating the tool once the at least one cutter is radially expanded. Insome embodiments, creating a wedge recess comprises rotating the toolwith the assistance of another device (e.g., mechanically-assisted,electromechanically-assisted, pneumatically-assisted device, etc.).

According to some embodiments, the at least one cutter comprises atleast two cutters. In some embodiments, the drill bit is cannulated, andwherein said drill bit is positioned over a guiding device (e.g., guidepin) to place a working end of the drill bit near a targeted location ofthe recess. In some embodiments, the implant is radially compressed andinserted within the wedge recess using an introducer. In someembodiments, an interior of the introducer is tapered to radiallycompress an implant as said implant is advanced through the introducer.In some embodiments, the interior of the introducer is tapered (e.g.,from larger to smaller diameter or cross-sectional dimension) from theproximal end to the distal end. In some embodiments, the interior of theintroducer is tapered (e.g., from larger to smaller diameter orcross-sectional dimension) from the distal end to the proximal end.

According to some embodiments, a distal end of the introducer is sizedand configured to fit at least partially within the recess. In oneembodiment, the implant is urged through an interior of the introducerusing a plunger or other pusher member. In some embodiments, the implantis urged through an interior of the introducer using amechanically-assisted device. In some embodiments, themechanically-assisted device comprises a handle and a clamp coupled tosaid handle, wherein moving the clamp relative to the handle urges aplunger within an introducer to radially compress the joint implant andinsert the joint implant within the recess. In one embodiment, the clampis rotatably coupled to the handle.

According to some embodiments, a ratio of the diameter or othercross-sectional dimension of the bottom opening of the wedge recess tothe diameter or other cross-sectional dimension of the surface openingof the wedge recess is approximately between 1.05 and 1.3. In someembodiments, a ratio of the diameter or other cross-sectional dimensionof the bottom opening of the wedge recess to the diameter or othercross-sectional dimension of the surface opening of the wedge recess isat least 1.1. In some embodiments, the diameter or other cross-sectionaldimension of the bottom opening of the wedge recess is approximately 5%to 25% larger than the diameter or other cross-sectional dimension ofthe surface opening of the wedge recess. In some embodiments, the toolis cannulated such that the tool is delivered to a targeted anatomicalsite over a guide pin or other guide tool or device.

According to some embodiments, a tool for creating a reverse taperedopening within tissue comprises an outer member comprising a distal end,the distal end comprising a tapered portion configured to be insertedwithin a cylindered opening created within tissue, a cutting memberpositioned along a distal end of the outer member, the cutting membercomprising at least one cutter configured to be radially expanded and aninner member configured to engage at least a portion of the outer memberand configured to be moved within an interior of the outer member,wherein a distal end of the inner member is configured to be movedwithin an interior of the cutting member, wherein radial expansion ofthe at least one cutter is configured to occur when the inner member ismoved within the interior of the cutting member, wherein the at leastone cutter is configured to be radially expanded at an angle relative toa longitudinal axis of the tool so as to create a reverse taperedopening within tissue when the tool is expanded and rotated.

According to some embodiments, the inner portion comprises a threadedportion configured to engage a corresponding threaded portion of theouter member. In some embodiments, wherein engaging the threaded portionof the inner portion relative to the corresponding threaded portion ofthe outer member selectively moves the inner portion relative to theouter member, in a longitudinal or axial direction of the tool. In oneembodiment, the at least one cutter comprises two cutters that areoriented opposite of each other. In some embodiments, the at least onecutter comprises two or more (e.g., 3, 4, 5, 6, more than 6, etc.)cutters.

According to some embodiments, the distal end of the outer membercomprises a tapered portion sized, shaped and configured to fit within acylindrical opening or recess. In some embodiments, the cutting memberis secured to a distal end of the outer member using at least one of apress-fit connection and a mechanical connection. In some embodiments,the at least one cutter comprises a sloped inner surface, such that whenthe inner member is advanced within an interior of the cutting member,the inner member engages and urges the at least one cutter radiallyoutwardly. In one embodiment, the tool comprises a metallic material(e.g., stainless steel, other metal and/or alloy, etc.). In someembodiments, the tool comprises a polymeric material. In someembodiments, the at least one cutter is configured to radially retractonce the inner member is retracted from an interior of the cuttingmember.

According to some embodiments, a method of creating for creating areverse tapered opening within tissue comprises creating a cylindricalopening within a targeted anatomical site of a subject using a firstdevice, and removing additional tissue from the sidewalls of thecylindrical opening using a cutting member of a tool to create a reversetapered opening within the targeted anatomical site using a seconddevice, wherein the tool comprises an inner member that is at leastpartially advanced relative to an outer member to radially expand acutting portion, the cutting portion comprising at least one cutter,wherein, once the reverse tapered opening is created, a diameter orother cross-sectional dimension of a bottom surface of the opening islarger than a diameter or other cross-sectional dimension of a topsurface of the opening. In some embodiments, the method additionallycomprises removing the tool from the opening.

According to some embodiments, a ratio of the diameter or othercross-sectional dimension of the bottom surface of the opening to thediameter or other cross-sectional dimension of the top surface of theopening is approximately between 1.05 and 1.3. In some embodiments, aratio of the diameter or other cross-sectional dimension of the bottomsurface of the opening to the diameter or other cross-sectionaldimension of the top surface of the opening is at least 1.1.

According to some embodiments, the first tool and the second tool arecannulated. In some embodiments, the first tool and the second tool arepositioned and aligned relative to the targeted anatomical locationusing a guide pin or other guiding device. In one embodiment, the firsttool comprises a drill bit. In some embodiments, the drill bit isconfigured to be rotated using a motorized device. In some embodiments,the drill bit is configured to be rotated using a manually-operateddevice.

According to some embodiments, the at least one cutter comprises atleast two cutters (e.g., 2, 3, 4, 5, 6, more than 6 cutters, etc.). Insome embodiments, the at least one cutter is configured to be radiallyexpanded at an angle relative to a longitudinal axis of the second tool.In some embodiments, the at least one cutter is configured to beradially expanded when an inner member of the second device is moved atleast partially within an interior of the cutting member. In someembodiments, the inner member of the second device is moved within theinterior of the cutting member by moving the inner member relative to anouter member of the second device.

According to some embodiments, the inner member is moved relative to theouter member using a threaded connection between the inner and outermembers. In some embodiments, the step of removing additional tissuefrom the sidewalls of the cylindrical opening to create a reversetapered opening comprises rotating the second device once the cuttingmember has been radially expanded. In some embodiments, the methodfurther comprises removing the second device once the reverse taperedopening has been created. In one embodiment, the step of removing thesecond device comprises radially retracting the cutting member andretracting the second device from the opening.

According to some embodiments, the second device is configured to bemanually rotated. In some embodiments, the second device is configuredto be rotated with the assistance of a motorized device. In oneembodiment, the method further includes securing an implant within thereverse tapered opening. In some embodiments, the implant is securedwithin the reverse tapered opening using an introducer. In someembodiments, the introducer comprises a tapered interior surface forradially compressing an implant that is advanced therethrough. In oneembodiment, the tapered interior portion of the introducer is locatedalong the proximal end of the introducer. In one embodiment, the taperedinterior portion of the introducer is located along the distal end ofthe introducer.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentapplication are described with reference to drawings of certainembodiments, which are intended to illustrate, but not to limit, thevarious inventions disclosed herein. It is to be understood that theattached drawings are for the purpose of illustrating concepts andembodiments of the present application and may not be to scale.

FIG. 1 schematically illustrates a side view of a tapered implantaccording to one embodiment;

FIG. 2 schematically illustrates a side view of the implant of FIG. 1positioned within a corresponding implant site, according to oneembodiment;

FIG. 3A illustrates a side view of a tapered implant according to oneembodiment;

FIG. 3B illustrates a top view of the tapered implant of FIG. 3A;

FIG. 4 illustrates a top view of an open mold assembly for makingtapered implants, according to one embodiment;

FIGS. 5 and 6 illustrate side views of the mold assembly of FIG. 4;

FIG. 7A illustrates a partial perspective view of one embodiment of atissue removal tool used to create a reverse tapered opening withintissue;

FIG. 7B illustrates a longitudinal cross-sectional view of the tissueremoval tool of FIG. 7A;

FIG. 7C illustrates a detailed perspective view of the distal end of thetissue removal tool of FIGS. 7A and 7C;

FIG. 7D illustrates a detailed perspective view of tissue removal toolof FIGS. 7A and 7B;

FIGS. 7E to 7G illustrate various views of the tissue removal tool ofFIG. 7A;

FIGS. 8A to 8C illustrate various views of the inner member of thetissue removal tool of FIG. 7A;

FIGS. 9A to 9C illustrate various views of the cutting portion of thetissue removal tool of FIG. 7A;

FIGS. 10A to 10C illustrate various views of the outer member of thetissue removal tool of FIG. 7A;

FIGS. 11A and 11B illustrate different perspective views of anotherembodiment of a tissue removal tool used to create a reverse taperedopening within tissue;

FIG. 11C illustrates a side view of the tissue removal tool embodimentof FIGS. 11A and 11B;

FIG. 11D illustrates an exploded perspective view of the tissue removaltool embodiment of FIGS. 11A and 11B;

FIG. 11E illustrates a longitudinal cross-sectional view of the tissueremoval tool embodiment of FIGS. 11A and 11B;

FIGS. 11F and 11G illustrate top and bottom views, respectively, of thetissue removal tool embodiment of FIGS. 11A and 11B;

FIG. 12A illustrates a perspective view of an implant introduceraccording to one embodiment;

FIG. 12B illustrates a side view of the introducer of FIG. 12A;

FIG. 12C illustrates a longitudinal cross-sectional view of theintroducer of FIG. 12A;

FIG. 13A illustrates a distal end view of the introducer of FIG. 12A;

FIG. 13B illustrates a detailed view along the neck portion of theintroducer depicted in FIG. 12A;

FIG. 14A illustrates a longitudinal cross-sectional view of anotherembodiment of an implant introducer;

FIG. 14B illustrates a cross-sectional view of an introducer comprisinga two-part construction according to one embodiment;

FIGS. 15A-15C illustrate time-sequential side views of an implant beinginserted within an implant site using the introducer of FIG. 12A;

FIG. 16A illustrates a perspective view of an assembled implant deliverytool according to one embodiment;

FIG. 16B illustrates an exploded view of the delivery tool of FIG. 16A;

FIG. 16C illustrates a cross-sectional view of the delivery tool of FIG.16A;

FIG. 16D illustrates a perspective view of an assembled implant deliverytool according to one embodiment;

FIG. 16E illustrates an exploded view of the delivery tool of FIG. 16D;

FIG. 17A illustrates a perspective view of an introducer;

FIG. 17B illustrates a cross-sectional view of the introducer of FIG.17A;

FIG. 18 illustrates a side view of a plunger;

FIG. 19A illustrates a perspective view of a handle;

FIG. 19B illustrates a top view of the handle of FIG. 19A;

FIG. 20A illustrates a side view of a clamp;

FIG. 20B illustrates another view of the clamp of FIG. 20A; and

FIGS. 21A-21C illustrate sequential views of an implant being movedthrough and deployed from a delivery tool.

DETAILED DESCRIPTION

The discussion and the figures illustrated and referenced hereindescribe various embodiments of a tool for creating a reverse tapered orwedge shaped opening or recess within bone or other tissue of a subject.The tool can be used to safely and efficiently create a wedge shapedopening by radially deploying one or more cutters of a cutting portionlocated at the distal end of the tool. In some embodiments, the tool ispositioned within a cylindrical opening prior to deploying the cutters.In some embodiments, the tool includes an inner member that isconfigured to engage an outer member and is configured to be movedwithin an interior of the outer member to selectively radially expandthe cutters. Once the cutters are radially expanded, the tool can berotated so the cutters can remove adjacent tissue to create the wedgeshaped recess or opening. In some embodiments, the tool can be rotatedmanually by the user (e.g., without the use of a drill or othermotorized device). In some embodiments, the tool is configured to createa wedge shaped opening with walls that are angled (e.g. relative to thelongitudinal axis of the opening) with a similar angle as an implantthat will be subsequently secured within the opening. An introducer canbe used to position an wedge shaped implant within the opening createdby the tool In several embodiments, a system or kit comprising one ormore tools, one or more introducers and/or one or more implants isprovided.

A number of the devices, systems and associated treatment methodsdisclosed herein are particularly well suited to replace deteriorated orotherwise damaged cartilage within a joint. Accordingly, suchembodiments can be used to treat osteoarthritis, rheumatoid arthritis,other inflammatory diseases, generalized joint pain and/or other jointdiseases. However, the various devices, systems, methods and otherfeatures of the embodiments disclosed herein may be utilized or appliedto other types of apparatuses, systems, procedures and/or methods,including arrangements that have non-medical benefits or applications.

According to several embodiments, implants are configured to remainwithin the patient's joint on a long-term basis (e.g., for most or allof the life of the patient), and as such, are configured, in someembodiments, to replace native cartilage. Thus, in some embodiments, theimplants are configured to be substantially non-biodegradable and/ornon-erodable. In some embodiments, for example, an implant is configuredto remain within the patient's joint or other portion of the anatomy fora minimum of 10 to 100 years or more (e.g., about 20, 25, 30, 35, 40,45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 years, durations betweenthe foregoing values, etc.) without losing its structural and/orphysical properties and/or without losing its ability to function as acartilage replacement component or device. Accordingly, such embodimentscan be used to treat osteoarthritis, rheumatoid arthritis, otherinflammatory diseases, generalized joint pain and/or other jointdiseases. However, the various devices, systems, methods and otherfeatures of the embodiments disclosed herein may be utilized or appliedto other types of apparatuses, systems, procedures and/or methods,including arrangements that have non-medical benefits or applications.Implants may be provided with or without an accompanying tool. Implants,which in some embodiments are provided with one or more tools describedherein, are also disclosed in US Publ. No 2013/0006368, filed on May 24,2012 as U.S. application Ser. No. 13/480,272 and published on Jan. 3,2013, which is hereby incorporated by reference in its entirety.

FIG. 1 schematically illustrates one embodiment of an implant 10intended for placement within or near a joint of a patient (e.g., toe,finger, ankle, knee, hip, shoulder, etc.). As shown, the implant 10 caninclude a generally tapered overall shape, wherein its base surface 14is larger than the opposite, top surface 16. As discussed in greaterdetail below, the smaller, top surface 16 can comprise the articulationsurface (e.g., a surface that is at least partially exposed to a joint),whereas the larger bottom or base surface 14 is securely retained withina corresponding opening specially created in the anatomy (e.g., throughbone, cartilage, other native tissue, etc.). As a result of such adesign, the sides 18 of the implant 10 can comprise a taper angle θ(e.g., relative to generally vertical sides), thereby giving the implanta generally truncated cone or frustum-like shape. As discussed ingreater detail herein, such a reverse-taper, wedge or truncated coneshape can help ensure proper securement of the implant 10 within apatient's anatomy.

FIG. 2 schematically illustrates an implant 10 similar to the onedepicted in FIG. 1 snugly positioned within a corresponding recessedarea R of a patient's tissue T (e.g., bone, cartilage, etc.). In someembodiments, such a recessed area R is formed at or near the patient'sjoint so that the implant 10 can be used to replace and/or augmentdamaged cartilage (e.g., on a long-term or permanent basis, as discussedabove). Alternatively, however, the implant 10 can be positionedgenerally away from a joint or other articulation surface. Thus, any ofthe implant embodiments disclosed herein, or equivalents thereof, can beused in a human or animal anatomy for a variety of different indicationsor other purposes, such as, for example, joint therapy, reconstructivesurgery, tissue augmentation, cosmetic surgery and/or the like. For anyof the embodiments disclosed herein, or equivalents thereof, the implant10 can be load bearing or non-load bearing, as desired or required. Insome embodiments, once implanted within the anatomy, the implant 10 isconfigured to be non-biodegradable for at least the expected useful lifeof the implant 10. In some embodiments, the implant 10 is adapted togenerally retain its general structure, shape, structure, size,strength, compressibility, function and/or other properties during thelife of the patient into which the implant is inserted. For example, theimplant 10 can be configured to generally maintain its originalphysical, chemical, biocompatibility and/or characteristics for at leastabout 100 years. In some embodiments, the implant retains the same orsubstantially the same water content, resiliency, durability, strength,coefficient of friction and/or any other properties for the period oftime that it is positioned within the anatomy of the patient. In otherembodiments, the implant 10 is configured to generally maintain itsoriginal physical, chemical, biocompatibility and/or characteristics forless or more than about 100 years (e.g., about 50 years, 60 years, 70years, 80 years, 90 years, 110 years, 120 years, 130 years, 150 years,200 years, more than about 200 years, less than about 50 years, etc.),as desired or required. In some embodiments, the implant 10 isconfigured to resist or substantially resist biodegradation or massreduction during such target time period.

With continued reference to FIG. 2, during delivery of the implant 10within the recess, the implant 10 can be compressed inwardly (e.g., asschematically depicted by the arrows 20). At least some methods ofdelivering such implants within an appropriately sized and shaped recessare discussed in greater detail herein. In some embodiments, once theimplant 10 has been properly positioned within the recess R, the implant10 is permitted to expand outwardly, thereby filling in or otherwiseencompassing all or substantially all of the volume of the recess R. Insome embodiments, the diameter or other cross-sectional dimension of thebase 14 of the implant 10 is greater than the corresponding diameter orother cross-sectional dimension of the recess R. This helps prevent theimplant 10 from moving out of the recess after implantation. The reversetapered shape of the implant 10 and the recess R into which it is placedcan help ensure that implant 10 remains securely within the recess Rfollowing implantation. In some embodiments, the outwardly directedforces of the implant 10 in the direction of the adjacent interiorsurfaces of the recess R assist in maintaining the implant 10 within therecess R during use (e.g., after implantation).

According to some embodiments, the base (or bottom) 14 and/or the top 16of the implant 10 is generally circular. Alternatively, the shape of theends 14, 16 can be different than circular, such as, for example, oval,square, other rectangular, other polygonal, irregular and/or the like.Further, once securely implanted in a patient's anatomy (e.g., within arecess R), the top 16 of the implant 10 can be generally flush with theadjacent tissue surface. However, in other embodiments, the top 16 ofthe implant 10 extends above the adjacent tissue T (e.g., as illustratedin FIG. 2) or below the adjacent tissue T following implantation. Forexample, in one embodiment, the top 16 of the implant is slightly“proud” or raised relative to the adjacent tissue (e.g., cartilage) inorder to reestablish a desired contour of the damaged joint surface. Insome embodiments, such a raised or otherwise protruding configurationcan assist in creating a smoother transition between the exposed surfaceof the implant 10 and adjacent native cartilaginous surfaces of a joint.

The top and/or bottom surfaces 16, 14 of the implant 10 can be generallyflat or planar. In other embodiments, the surface 16, 14 can benon-planar (e.g., curved, domed, convex, concave, fluted, ridged, etc.),as desired or required. The shape of the top and/or bottom surfaces canbe selected based on a patient's anatomy, the location within thepatient's anatomy in which the implant will be placed and/or one or moreother factors or considerations. For example, the implant can beconfigured to generally or specifically match the slopes, contoursand/or other features of the patient's existing cartilaginous and/orbone tissue, the recess and/or the like. Accordingly, the function of arehabilitated joint or other targeted anatomical region being treatedcan be improved.

Another embodiment of a tapered implant 110 configured to replace oraugment damaged cartilage within a patient is illustrated in FIGS. 3Aand 3B. As shown, the implant 110 can comprise a bottom or base surface114 and a top surface 116, which is at least partially exposed toadjacent anatomical tissues (e.g., other cartilaginous surfaces, bone,other portions that function as an articulating surface of a joint,etc.) after implantation. As with the implant of FIGS. 1 and 2, thedepicted embodiment includes a base 114 that is generally wider orotherwise larger than the top surface 116. For example, the diameter orother comparable cross-sectional dimension of the base can be largerthan that of the top. Accordingly, the implant 110 can include generallysloped sides 118 that terminate in a top surface 116 of small diameter(or other cross sectional dimension) than that of the base or bottomsurface 114. The sloped surfaces can be generally flat or curved, asdesired or required. Further, as shown in FIG. 3A, the transitionbetween the sides 118 and the top 116 can be rounded or otherwisesmooth. However, the transition from the side surfaces 118 to the top116 of the implant 110 can be more or less smooth than illustrated inFIG. 3A. In other words, in some embodiments, the radius of the curvedcorners is larger or smaller than disclosed herein. For example, asschematically illustrated in FIG. 1, an implant can comprise generallysharp transitions between the top surface and the sides.

As discussed herein with reference to FIGS. 1 and 2, the top, bottomand/or side surfaces of the implant 110 can be generally planar (e.g.,flat) or non-planar (e.g., curved, concave, convex, undulating, fluted,etc.), as desired or required. Further, although not illustrated in FIG.3A, the recess or other opening in which the implant 110 will bepositioned can include a similar reverse-tapered shape (e.g., having awider or large base and a smaller top) to help ensure that the implant110 remains securely in place following implantation. Additional detailsregarding reverse tapered openings within a patient's anatomy (e.g.,bone), including details related to tools and methods that help createsuch openings, are provided below.

With continued reference to FIGS. 3A and 3B, an implant 110 can includea generally circular or oval cross-sectional shape. Thus, in someembodiments, the implant 110 is generally shaped like a frustum,truncated cone, cylinder and/or the like. However, the overall shape ofany of the implants disclosed herein can vary depending on the specificapplication or use. For example, the shape of the base (or bottom), topand/or any other cross-sectional area of an implant can be generallyrectangular (e.g., square), other polygonal, irregular and/or the like.

Regardless of its exact size and shape, the base portion can be largeror wider than the top of the implant in order to help ensure that theimplant remains securely positioned within a targeted portion of apatient's anatomy (e.g., a joint) following implantation. For example,in some embodiments, the dimension (or area) of the base or bottom ofthe implant is approximately 10% to 15% (e.g., about 10%, 11%, 12%, 13%,14%, 15%, ranges between such values, etc.) longer, wider or otherwiselarger than the top of the implant. Thus, in embodiments havinggenerally circular bottom and top surfaces, such as, for example, theimplant 110 illustrated in FIGS. 3A and 3B, the diameter of the base orbottom 114 is approximately 10% to 15% (e.g., about 10%, 11%, 12%, 13%,14%, 15%, ranges between such values, etc.) larger than the diameter ofthe top 116. In other embodiments, the base 114 can be more than about15% larger or less than about 10% larger than the top 116, as desired orrequired. For example, in some embodiments, the diameter (or othercross-sectional dimension) of the base 114 is larger than the diameter(or other cross-sectional diameter) of the top 116 by approximately 1%,2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, less than 1%, other values between theforegoing percentages and/or the like. Alternatively, the diameter (orother cross-sectional dimension) of the base 114 is larger than thediameter (or other cross-sectional diameter) of the top 116 byapproximately 16%, 17%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 50%, 60%,more than 60% and/or the like.

According to some embodiments, for any of the implant arrangementsdisclosed herein, the ratio of the diameter (or other cross-sectionaldimension) of the base 114 to the diameter (or other cross-sectionaldimension) of the top 116 of the implant is between about 1 and about1.3 (e.g., approximately or more than 1.05, 1.06, 1.07, 1.08, 1.09, 1.1,1.11, 1.12, 1.13, 1.14, 1.15, 1.16, 1.17, 1.18, 1.19, 1.2, 1.21, 1.22,1.23, 1.24, 1.25, 1.26, 1.27, 1.28, 1.29, 1.3, values between theforegoing ratios, etc.). In other embodiments, the ratio is betweenabout 1 and 1.05 (e.g., approximately or greater than 1.01, 1.02, 1.03,1.04, 1.05), or greater than about 1.3 (e.g., approximately or more than1.3, 1.35, 1.4, 1.45, 1.5, 1.55, 1.6, greater than 1.6, etc.), asdesired or required.

As discussed above with reference to the embodiments illustrated inFIGS. 1-3B, an implant having a wedge or reverse tapered design (e.g.,an implant having a larger base than top) can help prevent or reduce thelikelihood of unintended ejection or other escape from the implant siteafter implantation. Thus, in some embodiments, the push-out force (e.g.,the force necessary to eject or otherwise remove the implant from theimplant site) is advantageously increased for wedge shaped implantsrelative to implants that do not include a wedge or reverse taper design(e.g., cylindrical implants, right angle implants, implants havinggenerally vertical sides, etc.). As a result, the likelihood ofmaintaining such embodiments within a joint or other part of the anatomyafter implantation is advantageously increased.

With continued reference to FIG. 2, the implant can be positioned withina recess or other opening formed within the patient's bone, cartilage orother tissue. As shown, in some embodiments, the implant 10 is sized,shaped and otherwise configured to fill all or most of the volume of therecess R once properly inserted therein. Further, according to someembodiments, the implant is radially oversized relative to thecorresponding implant site (e.g., recess, opening, etc.) into which itwill be placed. For example, an implant can be radially oversized byapproximately 5% to 15% (e.g., about 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%,13%, 14%, 15%, other percentages between such values, etc.) relative tothe implant site. In alternative embodiments, an implant can be radiallyoversized by less than about 5% or more than about 15%, as desired orrequired. In such oversized embodiments, once implanted, the implant canexert a radial or other outwardly directed force on the correspondingrecess. In some embodiments, such a configuration can help ensure thatthe implant remains securely within the recess after implantation. Inyet other embodiments, the implant comprises a similar or identical sizeas the implant site or is generally radially undersized relative to theimplant site.

As a result of the shape of the implant and the corresponding implantsite (e.g., recess, other opening, etc.), it may be necessary toradially compress the implant (e.g., inwardly, as schematicallyillustrated by the arrows 20 in FIG. 2) in order to insert the implantwithin the implant site. Accordingly, one or more introducers or otherdelivery tools can be used to facilitate the placement of a taperedimplant within an implant site. Additional inwardly-directed compressiveforces on the tapered implant may be required for implants that areradially oversized relative to the target implant site, as discussedabove. The degree to which an implant can be compressed (e.g.,circumferentially, radially inwardly, etc.) may depend on one or morefactors, properties, characteristics and/or other considerations, suchas, for example, implant size, water content, ingredients and othercomponents, strength, elasticity, surrounding temperature, method ofmanufacturing and/or the like.

According to some embodiments, radial compression of an implant canaffect the implant's overall height, the shape or contours of its outersurfaces (e.g., top or articulating surface, base or bottom surface,sides, etc.) and/or one or more other properties or characteristics ofthe implant. By way of example, in some embodiments, radial compressionof an implant causes the height of the implant to increase (e.g.,relative to the height of the implant when it is not radiallycompressed). Consequently, careful consideration may need to be given tothe design of the implant based on, among other things, the expectedlevel of radial compression that may occur once the implant has beenproperly secured within the implant site. Therefore, the amount ofradial compression, and thus its effect on the implant's diameter,height, other dimensions, shape and/or other properties, may need to becarefully determined prior to implantation. Otherwise, uponimplantation, an implant may not properly align with adjacent cartilageor other tissue surfaces in a joint or other anatomical location.

According to some embodiments, any of the implant embodiments disclosedherein comprise polyvinyl alcohol (PVA) hydrogels. The implants cancomprise one or more other materials, either in addition to or in lieuof PVA, such as, for example, other hydrogels, other polymericmaterials, other additives and/or the like. In some embodiments, the PVAcontent of a hydrogel is approximately 40% by weight. However, the PVAcontent of an implant can be less or more than about 40% by weight(e.g., approximately 10%, 15%, 20%, 25%, 30%, 32%, 34%, 36%, 37%, 38%,39%, 41%, 42%, 43%, 44%, 46%, 48%, 50%, 55%, 60%, 65%, 70% by weight,less than about 10% by weight, more than about 70% weight, valuesbetween the foregoing ranges, etc.), as desired or required.

Further, the implants can comprise water, saline, other liquids,combinations thereof and/or the like. In some embodiments, the use ofsaline within a hydrogel implant may be preferred over water, because,under certain circumstances, saline can help maintain osmotic balancewith surrounding anatomical tissues following implantation. The exactcomposition of an implant (e.g., PVA or other hydrogel materials, water,saline or other liquids, other additives, etc.) can be selected so as toprovide the resulting implant with the desired or required strength,load bearing capacity, compressibility, flexibility, longevity,durability, resilience, coefficient of friction and/or other propertiesand characteristics.

In several embodiments, the implants disclosed herein are configured fordrug delivery and/or are seeded with growth factors and/or cells. Insome embodiments, the implants comprise one or more of the following:chondrocytes, growth factors, bone morphogenetic proteins, collagen,hyaluronic acid, nucleic acids, and stem cells. Such factors and/or anyother materials included in the implant and selectively delivered to theimplant site can help facilitate and promote the long-term fixation ofthe implant within the joint or other target area of the anatomy.

In some embodiments, the implants disclosed herein are configured foranchoring during implantation. The implant can comprise one or moreanchor sites (which may comprise non-hydrogel portions or tabs) tofacilitate anchoring (e.g., suturing, stapling, etc.). In oneembodiment, the implant is pre-coupled to one or more anchors. Suchanchors can comprise removable and/or permanent fixtures. In someembodiments, the anchors are resorb able or otherwise dissolvable afterimplantation (e.g., following a particular time period, such as, forinstance, 1-30 days, 2-30 weeks, 6-12 months, 1-5 years, greater than 5years, less than 1 day, etc.). In one embodiment, the implant comprisesat least one abrasive surface. In one embodiment, the implant comprisesone or more adhesive components. In other embodiments, the tapered shapeof the implant permits secure implantation without the need for anyanchoring or other fixation. In some embodiments, for any of theimplants disclosed herein, one or more implant surfaces can beconfigured to promote bone adhesion by one or more coatings, substancesand/or the like and/or by using an appropriate surface texture along thesurface(s). For example, the implant surface can be roughened, caninclude pores (e.g., superficial pores) and/or any other feature, asdesired or required.

In some embodiments, the implants disclosed herein are supported orreinforced by a rigid support frame, such as a ceramic or metallicframe. In some embodiments, the implants disclosed herein are supportedor reinforced by a flexible or rigid mesh structure. In otherembodiments, the implants do not contain any support or reinforcementstructure.

Any of the implant embodiments disclosed herein, or equivalents thereof,can be manufactured using freeze/thaw cycling and/or any otherproduction method. For example, a hydrogel formulation comprising water,saline, PVA (and/or other hydrogel materials), other polymericmaterials, other additives and/or the like can be heated and/orotherwise treated as part of a freeze/thaw manufacturing process. In oneembodiment, a hydrogel solution comprising saline and about 40% PVA byweight is heated to approximately 121° C. under elevated pressureconditions (e.g., to affect dissolution of the polymer). For example,such a solution can be autoclaved in order to facilitate complete orsubstantially complete dissolution of the PVA in the saline, waterand/or other liquid. Next, the temperature and/or pressure of thesolution can be lowered to permit entrapped air and/or other gases toescape. In one embodiment, after the autoclaving or similar step, thesolution is generally maintained at a temperature of approximately 95°C. and atmospheric pressure for a predetermined time period.

The solution can then be transferred (e.g., pumped, poured, etc.) intoopen molds where, once set, will form the desired shape of the implants.One embodiment of such an open mold assembly 200 is illustrated in FIGS.4-6. As shown, the open mold assembly 200 can include a plurality ofindividual mold cavities 210, each of which is configured to receive ahydrogel solution. With specific reference to the cross sectional viewsof FIGS. 5 and 6, in some embodiments, the hydrogel solution isconfigured to fill only a lower portion 216 mold's assembly cavities210. Alternatively, the cavities can be filled with the desired hydrogelsolution to a level that is above the lower portion 216. Accordingly,under such circumstances, the resulting device that is formed thereinwill extend into the upper portion 212 of the cavity 210. As describedin greater detail below, any part of the device that extends above thelower portion 216 can be removed in order to produce an implant havinggenerally sloped or contoured side walls and a reverse tapered design,in accordance with various implant arrangements disclosed herein.

With continued reference to FIGS. 4-6, the cavities 210 of the moldassembly 200 can be shaped, sized and otherwise configured so that theimplants formed therein comprise a wedge, truncated cone or reversetaper design. For example, in such designs, the base ends of theimplants are generally larger than the corresponding, opposite top ends.Once the implants have been molded, they can be removed from the upperends of the assembly 200. The molded items can be removed either afterinitial formation or after they undergo additional treatment (e.g.,freeze/thaw cycling, other heat and/or pressure treatment, etc.). Asnoted above, depending on how much hydrogel solution is placed in thecavities, the molded implants removed from the cavities 210 of theassembly 200 may need to be cut, altered or otherwise processed. Forexample, in some embodiments, any portion of the implants formed by thegenerally cylindrical cavity section in the upper portion 212 of thecavities may need to be excised and discarded as part of a subsequentreshaping step. Accordingly, the remaining implants can generallyresemble the shape of the implant embodiment of FIGS. 3A and 3B or anyother implant having a generally reverse taper or wedge design.

Due in part to the remaining production steps, accommodation of anychanges in size (e.g., expansion, contraction, etc.) that may occur orare likely to occur to the implants can be considered duringmanufacturing by properly sizing and otherwise designing the moldassembly 200. The amount of contraction or expansion of the implants canbe based on one or more factors or conditions, such as, for example, thenumber of freeze/thaw cycles to which the implants are subjected, thetemperature and/or pressure ranges associated with the remaining stepsand/or the like.

Alternatively, the implants can be formed, at least in part, using aninjection molding process and/or any other molding or casting procedure.In such injection or transfer molding techniques, once the hydrogel orother implant solution has been prepared, it can be loaded into aninjection cylinder or other container of a molding press. The solutioncan then be forcibly transferred into a closed mold assembly using apneumatic or hydraulic ram or any other electromechanical device, systemor method. In some embodiments, the hydrogel and/or other solution orimplant component is injected into a corresponding closed mold assemblythrough a standard runner and gate system. Injection molding of implantscan provide one or more benefits relative to open mold assemblies. Forinstance, the devices formed as part of the injection molding techniquestypically do not require additional cutting, reshaping, resizing and/orprocessing, as they are essentially in their final shape immediatelyafter the injection molding step has been completed.

Regardless of how the implants are molded or otherwise shaped ormanufactured, they can be subsequently subjected to one or morefreeze/thaw cycles, as desired or required. In some embodiments, forexample, the implants, while in their respective mold cavities, arecooled using a total of four freeze/thaw cycles wherein the temperatureis sequentially varied between approximately −20° C. and 20° C. In otherembodiments, however, the number of freeze/thaw cycles, the temperaturefluctuation and/or other details related to cooling the implants can bedifferent than disclosed herein, in accordance with a specificproduction protocol or implant design.

Following freeze/thaw cycling, the implants can be removed from theirrespective mold cavities and placed in one or more saline and/or otherfluid (e.g., other liquid) baths where they can be subjected toadditional cooling and/or other treatment procedures (e.g., to furtherstabilize the physical properties of the implants). According to someembodiments, for instance, the implants undergo an additional eightfreeze/thaw cycles while in saline. In other embodiments, such follow-upcooling procedures are either different (e.g., more or fewer freeze/thawcycles, different type of bath, etc.) or altogether eliminated from theproduction process, as desired or required.

When the cooling (e.g., freeze/thaw cycling) and/or other treatmentsteps have been completed, the implants can be inspected to ensure thatthey do not include any manufacturing flaws or other defects. Further,at least some of the implants can be subjected to selective testing toensure that they comprise the requisite physical and othercharacteristics, in accordance with the original design goals and targetparameters for the implants. Further, it may be necessary to cut orotherwise process the implants in order to remove any excess portions.In some embodiments, the completed implants are packaged in hermeticallysealed plastic trays (or other containers) comprising foil or othertypes of lids or covering members. A volume of saline and/or otherliquid can be included within such trays or other containers to ensureproper hydration of the implants during storage and/or any other stepspreceding actual use. In one embodiment, the implant trays or othercontainers are terminally sterilized using e-beam exposure between about25 and 40 kGy. Additional details related to producing hydrogel implantscan be found in U.S. Pat. Nos. 5,981,826 and 6,231,605, the entiretiesof both of which are hereby incorporated by reference herein.

According to some embodiments, the overall height (e.g., between thebase or bottom surface and the top or articulating surface) of a taperedimplant is approximately 10 mm. Further, the diameter or othercross-sectional dimension along or near the top surface of the implantcan be about 10 mm. However, in other embodiments, the height, diameterand/or other dimensions of a wedge-type implant can vary, as desired orrequired. For example, implants adapted for use in larger joints (e.g.,knee, shoulder, hip, etc.) can have a height and/or diameter larger than10 mm (e.g., about 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 18 mm, 20mm, greater than 20 mm, dimensions between the foregoing values, etc.).Likewise, implants configured for use in smaller joints (e.g., toes) canbe smaller than 10 mm in height (e.g., about 2 mm, 4 mm, 6 mm, 8 mm)and/or 10 mm in top diameter (e.g., about 2 mm, 4 mm, 6 mm, 8 mm).

As discussed above with reference to FIGS. 1 and 2, in order to ensurethat the implant securely remains within a joint or other anatomicallocation following implantation, the implant can be positioned within animplant site that also comprises a similar reverse taper, wedge ortruncated cone shape. Accordingly, several embodiments of making such atapered recess or other opening within bone tissue are described ingreater detail below.

FIG. 7A illustrates a partial perspective view of one embodiment of atool 1000 that can be used to create a reverse tapered or wedge-shapedopening within bone or other tissue. In FIG. 7A, an outer tube or memberis not shown for clarity. FIG. 7B illustrates a longitudinalcross-sectional view of the tool 1000. As shown in FIGS. 7A and 7B, thetool 1000 comprises an inner member 1030 that engages an outer member1010. In the illustrated embodiment, the proximal end of the innermember 1030 comprises a threaded portion 1034 that is sized, shaped andotherwise configured to engage a corresponding threaded portion 1014 ofthe outer member 1010. Thus, as discussed in greater detail herein, theinner member 1030 can be predictably and securely positioned within andadvanced relative to the outer member 1010 during use. In otherembodiments, the inner member and the outer member include one or moreother features that help couple and/or otherwise engage one anotherand/or that help selectively advance the inner member 1030 relative tothe outer member 1010. For example, the outer and inner members 1010,1030 can include protruding and corresponding recesses, other mechanicalengagement features, one or more couplings, one or more alignmentmembers or features and/or the like, either in lieu of or in addition tothreaded portions or sections, as desired or required.

As discussed in greater detail herein, the use of a tool, such as theone illustrated in FIGS. 7A and 7B, can facilitate the creation of areverse tapered or wedge opening within a targeted bone or otheranatomical tissue of a subject. Such an opening can be used to receive asimilarly shaped implant (e.g., a hydrogel implant, anothercartilage-replacement implant, other synthetic materials, native tissueof a subject, etc.). As noted herein, the use of such openings withinbone or other tissue can help ensure that an appropriately shapedimplant placed therein will safely and securely remain in placepost-implantation. For example, the shape of the opening and the implantwill help ensure that the implant is mechanically maintained within theopening without the need for separate securement (e.g., fixation) of theimplant to the subject's anatomy.

With continued reference to FIGS. 7A and 7B, the proximal end of theinner member 1030 can include a handle 1035 or other portion that can begrasped and easily manipulated by a surgeon or other user. For example,in some embodiments, in order to threadably engage the inner member 1030to the outer member 1010, the proximal handle 1035 (and thus, the innermember 1030) is rotated relative the outer member 1030. As a result, thethreaded portion 1034 of the inner member 1030 can engage thecorresponding threaded pattern 1014 of the outer member, therebysecuring the inner member to the outer member. As the handle 1035 isrotated in a first direction (e.g., clockwise) relative to the outermember 1010, the inner member 1030 can be longitudinally or axiallyadvanced within the outer member 1010 (e.g., in a distal direction).Likewise, in order to longitudinally retract the inner member 1030 fromthe outer member 1010, the inner member 1030 can be rotated in a second,opposite direction (e.g., counterclockwise) relative to the outer member1030. In some embodiments, the threaded patterns 1014, 1034 of the outerand inner members can be oriented in a different direction.

With continued reference to FIG. 7B, the outer member 1010 can furtherinclude a proximal handle 1012 that can be grasped and manipulated by aphysician or other practitioner during use. As discussed in greaterdetail herein, the handle 1012 of the outer member 1010 can be used torotate or otherwise move the entire tool 1000 relative to a subject'stissue (e.g., bone) once the inner member 1030 has been advanced deepenough within the outer member 1010. Such a movement helps excise orremove bone and/or tissue of the subject (e.g., to help create the wedgeor reverse tapered shape).

In some embodiments, the inner member 1030 is cannulated or otherwiseincludes one or more openings (e.g., along its longitudinal or axialcenterline). As shown in the longitudinal view of FIG. 7B, a centralopening 1036 of the inner member 1030 can extend along the entire lengthof the inner member 1030, including the proximal handle 1035. Such anopening 1036 can permit the tool 1000 to be placed over a guide pin orother guiding tool to help assist with the accurate positioning of thetool, and thus the creation of a reverse-tapered or wedge opening,during use. In some embodiments, such an opening 1036 can be helpful inremoving excised bone tissue that has been cut during a procedure. Forexample, in some embodiments, a rod or other device can be insertedwithin the opening 1036 to push bone material distally (e.g., out thedistal end of the outer member and the entire tool). In otherembodiments, a vacuum or suction force can be applied to the opening1036 to selectively pull out excised bone and/or other tissue. Suchprocedure can be performed during, before or after a cutting procedure,as desired or required. In some embodiments, one or more liquids and/orother fluids (e.g., water, saline, medicaments, etc.) can becontinuously or intermittently provided through the opening 1036 duringuse. Such fluids can assist in executing a particular protocol (e.g., toprovide a desired degree of moisture or lubrication to facilitate thecutting process and/or the movement of the device during use, etc.).

As depicted in FIGS. 7A and 7B, a cutting portion or cutting member 1020can be positioned along the distal end of the outer member 1010. In someembodiments, the cutting portion 1020 is secured to the outer member1010 using one or more attachment devices or methods, such as, forexample, a press-fit connection, adhesives, welds, screws, tabs and/orother mechanical fasteners and/or the like. However, in otherembodiments, the cutting portion 1020 is a stand-alone component ormember that is separate and distinct from the outer member 1010 and/orthe inner member 1030. For example, in some embodiments, the cuttingmember 1020 is configured to be retained within an interior of the outermember 1010 using one or more features (e.g., proximal lip that abutsand stops relative to an adjacent lip or feature along an interior ofthe outer member 1010, a flange that abuts a corresponding feature ofthe inner member 1010, etc.). In some embodiments, the cutting portion1020 comprises two oppositely-positioned cutters 1024 that areconfigured to be radially expanded during use. However, in otherembodiments, the cutting portion 1020 can include more than 2 (e.g., 3,4, 5, 6, more than 6, etc.) cutters 1024, as desired to required.

With reference to FIGS. 7B and 7C, each of the cutters 1024 comprises asloped interior surface (e.g., with the thicker portion located alongtheir distal end of each cutter 1024). As discussed in greater detailherein, such a design can be used to radially expand the cutters 1024when the inner member 1030 is moved within the interior of the cuttingportion 1020 (e.g., in a direction represented by arrow T in FIGS. 7Band 7C).

According to some embodiments, the various components of the tool 1000,including the inner and outer member 1030, 1010 and/or the cuttingportion or member 1020 comprise one or more rigid and/or semi-rigidmaterials that are configured to withstand the forces, moments,chemicals and/or other substances, temperature fluctuations and/or otherelements to which they may be exposed. For example, the components ofthe tool can comprise one or more metals (e.g., stainless steel, othersurgical steel, other types of steel, etc.), alloys, plastics and/or thelike. Such materials can permit the device to be autoclaved, sterilizedor otherwise cleaned during a specific disinfection protocol, and thus,reused for multiple procedures. In some embodiments, the tool 1000 caninclude polymeric materials and/or other materials that make it moreconducive for the tool 1000 to be disposable and/or replaceable afteruse.

According to some embodiments, the outer and inner members 1010, 1030comprise, consist of or consist primarily of a polymeric material, suchas, for example, medical grade polycarbonate, while the cutting portion1020 comprises, consists of or consists primarily of a metal and/oralloy, such as, for example, stainless steel. In some embodiments, theouter member 1010 can comprise a two-part construction. For example, insome embodiments, the distal end of the outer member includes an insertcomprising a metal and/or alloy (e.g., stainless steel), whereas theproximal portion of the outer member comprises a different material,such as, for example, a polymeric material (e.g., polycarbonate). Such aconfiguration can help create a lower cost outer member, and thus, tool.In some embodiments, the outer member 1010 and/or any other component ofthe tool 1000 can be disposable and/or reusable, as desired or required.

In other embodiments, the two or more portions of a multi-partconstruction for the outer member can comprise the same or similarmaterials. For example, the embodiment depicted in FIGS. 11A to 11Gincludes an outer member 2010 comprising a proximal portion 2011A and adistal portion 2011B. In some arrangements, each of the proximal anddistal portions 2011A, 2011B of such an outer member 2010 can comprisestainless steel, another metal or alloy and/or any other material. Inother configurations, however, the proximal portion 2011A comprises oneor more different materials than the distal portion 2011B of the outermember 2010, as desired or required.

FIGS. 7E to 10C provide additional views of one embodiment of the tooland its various components. For example, FIG. 7E illustrates aperspective view of the tool 1000 with the inner member 1030 positionedat least partially within the outer member 1010. As depicted in FIG. 7Eand discussed in greater detail herein, the tool 1000 can be cannulatedin order to permit the tool to be positioned over a guide pin or otherguiding member GP. In some embodiments, as described herein, the innermember 1030 can be cannulated such that it includes a central lumen oropening 1036 (see, e.g., FIGS. 7B, 7G, 8C, 11E, etc.). As shown, thelumen or opening along the distal end 1038 of the inner member 1030 canbe smaller (e.g., can include a smaller diameter or cross-sectionaldimension) than a proximal portion of the lumen or opening 1036.However, in other arrangements, the lumen or opening along the distalend of the inner member can be the same size or larger than a proximalportion of the lumen of opening, as desired or required.

With continued reference to FIGS. 7E to 7F, the distal end of the outermember 1010 can be tapered. For example, as discussed in greater detailherein, such a tapered distal portion of the outer member 1010 can besized, shaped and configured to fit within a cylindrical opening createdwithin a targeted bone surface or other tissue. In some embodiments, amanually operated tool 1000, 2000 to create a desired wedge or reversetapered shape within a target bone of subject, in accordance with thearrangements disclosed herein, can be configured to be used after acylindrical opening or cavity has been created by a separate tool ordevice. As depicted in the perspective view of FIG. 7E, the distal endof the outer member can include one or more slots or openings throughwhich the cutters 1024 can pass when the cutting portion 1020 isradially expanded (e.g., when the inner member 1030 is advancedsufficiently far enough within an interior of the outer member 1010).One or more additional slots or openings can also be provided along thedistal end of the outer member (separate and aside from the slots oropenings through which the cutters pass). Such additional slots oropenings can assist in receiving excised bone and/or any other nativetissue of the subject removed during a procedure.

FIGS. 8A to 8C illustrate different views of one embodiment of an innermember 1030 configured for use with a bone or other tissue removal tool1000. With reference to the longitudinal cross-section view of FIG. 8C,in some embodiments, the length L2 of the inner member 1030 can bebetween 4 and 6 inches (e.g., 4-4.2, 4.2-4.4, 4.4-4.6, 4.6-4.8, 4.8-5,5-5.2, 5.2-5.4, 5.4-5.6, 5.6-5.8, 5.8-6 inches, lengths between theforegoing ranges, etc.). In one embodiment, the length L2 of the innermember 1030 is approximately 4.8 inches (122 mm). However, in otherembodiments, the length L2 of the inner member 1030 can be less than 4inches or greater than 6 inches, as desired or required. With continuedreference to FIG. 8C, the outer diameter or cross-sectional dimension D2along the distal end 1038 of the inner member 1030 (as well as the mainshaft portion in the depicted embodiment) can be approximately 0.35inches (8.9 mm). In some embodiments, the outer diameter orcross-sectional dimension D2 along the distal end 1038 of the innermember 1030 is between 0.2 and 0.5 inches (e.g., 0.2-0.25, 0.25-0.3,0.3-0.35, 0.35-0.4, 0.4-0.45, 0.45-0.5 inches, dimensions between theforegoing ranges, etc.). In other embodiments, the outer diameter orcross-sectional dimension D2 can be less than 0.2 inches or greater than0.5 inches, as desired or required for a particular tool or application.

FIGS. 9A to 9C illustrate different views of one embodiment of a cuttingportion 1020 configured for use with a tool 1000. As shown and discussedwith reference to other figures herein, the cutting portion or cuttingmember 1020 can include a cylindrical proximal portion 1022 and one ormore cutters 1024 that extend distally from the cylindrical portion1022. In some embodiments, the cutting portion 1020 is sized, designedand otherwise configured to fit within and be secured to the outermember 1010 (see, e.g., FIGS. 7B and 7G). In some embodiments, thecutting portion 1020 is press fit within an interior of the outer member1010; however, the cutting portion can be secured to the outer memberand/or any other component or portion of the tool 1000 using one or moreother attachment methods or devices (e.g., adhesives, welds, rivets,fasteners, etc.). In other embodiments, the cutting member 1020 issized, shaped and otherwise configured to abut one or more surfaces orother portions along the distal end of the outer member 1010. Such aconfiguration can help maintain the longitudinal location of the cuttingportion or member 1020 relative to the outer member 1010, and thus thetool 1000, during use.

With continued reference to FIGS. 9A to 9C, in some embodiments, thecutters 1024 include one or more recesses or other features 1023 alongat least a portion of their length. Such recesses or features 1023 canbe shaped, sized and otherwise configured to match correspondingfeatures along an interior of the outer member 1010 (e.g. for securingthe cutting portion 1020 to the outer member 1010 or otherwise limitingmovement between the cutting portion and the outer member). Further, asdiscussed in greater detail herein, the cutters 1024 can be sloped orotherwise tapered along their interior. In some embodiments, thispermits the cutters 1024 to be radially expanded when the inner member1030 in advanced within an interior of the cutters 1024. The slope ortaper along the interior surfaces of the cutters 1024 permits the radialexpansion of the cutters to occur gradually. In some embodiments, thecutters 1024 normally assume a retracted shape. Thus, in suchembodiments, once an inner member 1030 is withdrawn from an interior ofthe cutting portion 1020, the cutters 1024 re-assume a retractedorientation. Accordingly, in some embodiments, the cutters 1024 areresiliently biased (e.g., inwardly) and configured to be urged outwardly(e.g., by the passage of distal end of the interior member 1030 throughan inner passage of the cutting member 1020) in order to flare out orotherwise expand the distal end of the tool. It is the rotation of thetool in such a flared out configuration that helps create the desiredwedge or reverse tapered opening within a targeted bone or other tissueof a subject.

With reference to the longitudinal cross-sectional view of FIG. 9C, insome embodiments, the outer diameter or cross-sectional dimension D3 aalong the distal end of the cutting portion 1020 (e.g., when the cutters1024 are radially retracted) is 0.3 to 0.7 inches (e.g., 0.3-0.35,0.35-0.4, 0.4-0.45, 0.45-0.5, 0.5-0.55, 0.55-0.6, 0.6-0.65, 0.65-0.7inches, dimensions between the foregoing, etc.). In one embodiment, theouter diameter or cross-sectional dimension D3 a along the distal end ofthe cutting portion 1020 (e.g., when the cutters 1024 are radiallyretracted) is approximately 0.5 inches (approximately 12.7 mm). Further,in some embodiments, the inner diameter or cross-sectional dimension D3b along an interior of the proximal (e.g., cylindrical) end of thecutting portion 1020 is 0.2 to 0.7 inches (e.g., 0.2-0.25, 0.25-3,0.3-0.35, 0.35-0.4, 0.4-0.45, 0.45-0.5, 0.5-0.55, 0.55-0.6, 0.6-0.65,0.65-0.7 inches, dimensions between the foregoing, etc.). In oneembodiment, the inner diameter or cross-sectional dimension D3 b alongan interior of the proximal (e.g., cylindrical) end of the cuttingportion 1020 is approximately 0.35 inches (approximately 9 mm).

As discussed herein, when the inner member 1030 is advanced within theinterior of the cutting portion or member 1020, the cutters 1024 of thecutting portion or member can be radially expanded. In some embodiments,the cutters 1024 are radially expanded such that their outer diameter orother cross-sectional dimension after full expansion is 30% to 70%(e.g., 30-35, 35-40, 40-45, 45-50, 50-55, 55-60, 60-65, 65-70%,percentages between the foregoing, etc.) greater than their outerdiameter or other cross-sectional dimension D3 a when retracted. Due tothe sloped inner surfaces of the cutters 1024, once fully radiallyexpanded, the cutters 1024 will be angled relative to the longitudinalaxis of the tool and relative to the walls of the cylindrical opening.In some embodiments, the angle of the expanded cutters 1024 relative tothe longitudinal axis of the cutting portion or member 1020 (and thus,the entire tool 1000) is between 0 and 45 degrees (e.g., 0-1, 1-2, 2-3,3-4, 4-5, 5-6, 6-7, 7-8, 8-9, 9-10, 10-11, 11-12, 12-13, 13-14, 14-15,15-16, 16-17, 17-18, 18-19, 19-20, 20-21, 21-22, 22-23, 23-24, 24-25,25-26, 26-27, 27-28, 28-29, 29-30, 30-31, 31-32, 32-33, 33-34, 34-35,35-36, 36-37, 37-38, 38-39, 39-40, 40-41, 41-42, 42-43, 43-44, 44-45degrees, angles between the foregoing, etc.). In other embodiments, suchan angle is greater than 45 degrees (e.g., 45-50, 50-55, 55-60 degrees,angles between the foregoing ranges, more than 60 degrees, etc.), asdesired or required. The angles of the expanded cutters relative to alongitudinal axis of the tool discussed above can apply to any wedgecreation tool embodiments disclosed herein, including, withoutlimitation, the tool 2000 illustrated in FIGS. 11A to 11G.

FIGS. 10A to 10C illustrate various views of an outer member 1010configured for use with a bone or other tissue removal tool 1000. Asdiscussed in greater detail herein, the distal end 1019 of the outermember 1010, and thus the tool 1000, can be tapered (e.g., can include asmaller outer diameter or other cross-sectional dimension) to permit thetool to be positioned within a cylindrical opening or recess of atargeted bone or other anatomical tissue. As noted, for example, thetool 1000 can be configured to be used after another tool has been usedto create a cylindrical opening within the targeted bone of the subject.In some embodiments, the distal end 1019 of the outer member 1010 of thetool can include a cylindrical shape that is sized, shaped and otherwiseconfigured to fit within the cylindrical opening created by a first tool(e.g., another manually operated device, a non-manual (e.g., electric,pneumatic, etc.) drill or other tool and/or the like. Thus, as shown in,e.g., FIGS. 7B, 10A and 10C, the distal end of the outer member 1010 caninclude a tapering feature. In some embodiments, as included in thedepicted configuration, such a tapering feature comprises a step orother abrupt feature. However, in other embodiments, any taper includedalong the distal end of the inner portion 1010 can be gradual (e.g., thedistal end of the outer member does not include a step or other abruptfeature), as desired or required.

With continued reference to FIGS. 10A to 10C, as discussed herein, thedistal end of the outer member 1010 can include one or more slots orother openings through which the cutters 1024 of the cutting portion1020 can pass as those cutters are radially expanded. As depicted inFIG. 10B, the size Cl of each opening along distal end of the outermember 1010 is 0.1 to 0.3 inches (e.g., 0.1-0.15, 0.15-0.2, 0.2-0.25,0.25-0.3 inches, dimensions between the foregoing, etc.). In oneembodiment the size Cl of each opening along distal end of the outermember is approximately 0.1 inches (4 mm). As shown in the longitudinalcross-sectional view of FIG. 10C, the length L1 of the outer member 1010is between 4 and 6 inches (e.g., 4-4.2, 4.2-4.4, 4.4-4.6, 4.6-4.8,4.8-5, 5-5.2, 5.2-5.4, 5.4-5.6, 5.6-5.8, 5.8-6 inches, lengths betweenthe foregoing ranges, etc.). In one embodiment, the length L1 of theouter member 1010 is approximately 4.4 inches (112 mm). However, inother embodiments, the length L1 of the outer member 1010 can be lessthan 4 inches or greater than 6 inches, as desired or required.

With continued reference to FIG. 10C, the outer diameter orcross-sectional dimension D1 a of the outer member 1010 (e.g., along aproximal end of the outer member) is 0.5 to 1 inches (e.g., 0.5-0.6,0.6-0.7, 0.7-0.8, 0.8-0.9, 0.9-1 inches, dimensions between theforegoing, etc.). In one embodiment, the outer diameter orcross-sectional dimension D1 a of the outer member 1010 (e.g., along aproximal end of the outer member) is approximately 0.8 inches(approximately 20 mm). As illustrated in FIG. 10C and discussed ingreater detail herein, in some embodiments, the outer member 1010 istapered, such that its outer diameter decreases along at least a portionof its distal end. Further, as shown in FIG. 10C, the distal most end1019 of the outer member 1010 can include a step-like and/or otherabrupt feature (e.g., where the diameter of the outer member changesquickly). As discussed herein, in some embodiments, the smaller diameterdistal end of the outer member 1010 is sized, shaped and configured tofit within a cylindrical opening that is initially created in thetargeted bone or other tissue where the reverse-tapered or wedge openingwill be created.

According to some embodiments, the outer diameter or cross sectionaldimension D1 b of the distal most section 1019 of the outer member 1010is 0.3 to 0.7 inches (e.g., 0.3-0.4, 0.4-0.5, 0.5-0.6, 0.6-0.7 inches,dimensions between the foregoing, etc.). In one embodiment, the outerdiameter or cross sectional dimension D1 b of the distal most section1019 of the outer member 1010 is approximately 0.56 inches(approximately 14.3 mm). However, in other embodiments, the outerdiameter or cross sectional dimension D1 b of the distal most section1019 of the outer member 1010 can be less than 0.3 inches or greaterthan 0.7 inches, as desired or required. In some embodiments, the innerdiameter or cross sectional dimension D1 c formed by distal most section1019 of the outer member 1010 is 0.2 to 0.6 inches (e.g., 0.2-0.3,0.3-0.4, 0.4-0.5, 0.5-0.6 inches, dimensions between the foregoing,etc.). In one embodiment, the inner diameter or cross sectionaldimension D1 c of the distal most section 1019 of the outer member 1010is approximately 0.42 inches (approximately 10.7 mm). However, in otherembodiments, the inner diameter or cross sectional dimension D1 c of thedistal most section 1019 of the outer member 1010 can be less than 0.2inches or greater than 0.6 inches, as desired or required.

The various tool embodiments disclosed herein (e.g., with reference toFIGS. 7A to 11G) can be used to create a reverse-tapered or wedge shapedopening in any bone surface and/or other tissue of a subject. Forexample, in some embodiments, the tool 1000, 2000 can be used to createan opening in a bone adjacent a subject's knee, shoulder, foot, arm,wrist, hand and/or the like. As discussed in greater detail herein, thetool 1000, 2000 can be used to manually create a reverse-tapered orwedge shaped opening within a bone surface or other targeted tissue of asubject manually (e.g., without the use of a drill or other motorizedtool). Thus, the creation of such wedge shaped openings can be made in asafer and more predictable manner by using the tool 1000, 2000 orvariations thereof.

According to some embodiments, as a first step of the reverse-tapered orwedge shaped opening, a user creates a cylindrical opening within atargeted bone or other tissue surface of the subject. In order to createsuch a cylindrical opening, a motorized drill can be used. However, inother embodiments, the cylindrical opening can be created manuallyand/or using any other device or method. In some embodiments, a tool(e.g., motorized drill, hand or manually-operated drill, etc.) can becannulated so that it can be predictably and accurately positionedrelative to the targeted bone surface using a guide pin or other guidingtool. Thus, in some embodiments, after the targeted bone surface hasbeen prepared for creation of the opening, a guide pin or other guidingdevice can be accurately positioned on such a targeted surface. Acannulated drill or other device can then be placed over the guide pinor other guiding device and operated so as to create the desiredcylindrical opening within the bone or other surface.

According to some embodiments, a first step in creating a reversetapered or wedge shaped opening within bone or other targeted tissue ofa subject includes using a drill bit or other motorized or manual deviceto create a cylindrical recess or opening. In some arrangements, a bonedrill can be used to selectively rotate or otherwise manipulate thedrill bit. The bone drill can be either manually operated or powerdriven (e.g., mechanically, pneumatically, hydraulically, etc.). In someembodiments, such a drill bit can include a flange and one or moreabrading members or cutters extending distally from the flange. Such aflange or other feature can ensure that the cylindrical opening iscreated with a specific depth, as the flange or other feature willprevent further movement of a drill or other device from advancingdeeper into targeted bone tissue. In some embodiments, a drill bit canbe cannulated, such that one or more passages or openings extend (e.g.,longitudinally) through the device. For example, such a passage cangenerally extend from the proximal end of the drill bit to the distalend, terminating in an opening along a distal hub to which the cuttersare secured. The inclusion of such passages or openings can help ensurethat the drill bit is accurately positioned within a patient's joint orother portion of the anatomy before commencing a drilling procedure.

In some embodiments, as a drill bit is rotated (e.g., either manually orusing one or more external driving sources, etc.), sharp edges formedalong the distal and/or peripheral portions of its cutters can abradeand remove cartilage, bone and/or other tissue that they engage andcontact. In some embodiments, the longitudinal distance between thedistal face of the drill bit's flange member and the distal ends of thecutters can limit the depth of the recess or opening that is createdwithin the patient's bone or other anatomical area. Likewise, theperipheral surfaces of the cutters can define a diameter or othercross-sectional dimension that effectively limits the diameter of theresulting recess or other openings in the patient's bone or othertargeted tissue. Thus, the drill bit can be configured to create animplant site having specific dimensions (e.g., depth, diameter, etc.).Consequently, in some arrangements, drill bits of varying size and shapeare available to the surgeon or other clinician in order to accuratelycreate a specific desired implant site within the patient.

Once a cylindrical opening has been created to a desired depth, thedrill or other device that was used to create the cylindrical openingcan be removed. In some embodiments, the depth and diameter of thecylindrical opening is selected based on the size of implant that willbe inserted therein. For example, the depth of the cylindrical opening(e.g., relative to the top surface of the bone or other tissue in whichthe opening is made) can be between 4 and 16 mm (e.g., 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, 15, 16 mm, depths between the foregoing, etc.).However, in other embodiments, the depth can be less than 4 mm (e.g.,0-1, 1-2, 2-3, 3-4 mm, depths between the foregoing, etc.) or greaterthan 16 mm (e.g., 16-18, 18-20 mm, greater than 20 mm, etc.), as desiredor required. Likewise, the diameter or other cross-sectional of theopening can be between 4 and 16 mm (e.g., 4, 5, 6, 7, 8, 9, 10, 11, 12,13, 14, 15, 16 mm, dimensions between the foregoing, etc.). However, inother embodiments, the diameter can be less than 4 mm (e.g., 0-1, 1-2,2-3, 3-4 mm, dimensions between the foregoing, etc.) or greater than 16mm (e.g., 16-18, 18-20 mm, greater than 20 mm, etc.), as desired orrequired.

Next, in some embodiments, a wedge-creation tool 1000, 2000, inaccordance with one or more of the configurations disclosed herein, canbe inserted within the cylindrical opening. For instance, in somearrangements, as illustrated in FIGS. 7A-10C, the distal portion of theouter member 1010 can be tapered so that such a tapered portion snuglyfits within the cylindrical opening. Thus, in some embodiments, variouscombinations of depths and diameters of tools 1000 can be manufacturedand selectively provided to a user, based, at least in part, on thepossible reverse-tapered or wedge opening dimensions desired by suchuser. In some embodiments, once the distal tapered portion of the outermember 1010 can been properly secured within the cylindrical opening,the user can begin the process of creating the desired wedge shapewithin such opening. As noted above, in some embodiments, the tool 1000can be cannulated so that the tool can be accurately and predictablydelivered within the desired cylindrical opening over a guide pin orother guiding device.

With continued reference to FIG. 7B, once the distal end of the tool hasbeen properly secured within a cylindrical opening, the user can rotatethe proximal handle 1035 of the inner member 1030 to advance the innermember 1030 relative to (e.g., within) the outer member 1010. In someembodiments, the user advances the inner member 1030 fully within theouter member 1010 such that the handle 1035 can no longer be rotated. Insome embodiments, as the inner member 1030 is advanced within the outermember 1010, the distal end of the inner member will move within aninterior of the cutters 1024 of the cutting member 1020 (e.g., in adirection generally represented in FIGS. 7B and 7C by arrow T). As thedistal member moved within the interior of the cutting member 1020, thecutters will be radially expanded by the inner member 1030 (e.g., in adirection generally represented in FIG. 7B by arrows E). As the cuttersare forced radially outwardly, they will be forced through adjacenttissue (e.g. bone) along the walls of the cylindrical opening. Due tothe sloped inner surfaces of the cutters 1024, once fully radiallyexpanded, the cutters 1024 will be angled relative to the longitudinalaxis of the tool and relative to the walls of the cylindrical opening.For example, in some embodiments, the angle of the expanded cutters 1024relative to the longitudinal axis of the cutting portion or member 1020(and thus, the entire tool 1000) is between 0 and 45 degrees (e.g., 0-1,1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-9, 9-10, 10-11, 11-12, 12-13,13-14, 14-15, 15-16, 16-17, 17-18, 18-19, 19-20, 20-21, 21-22, 22-23,23-24, 24-25, 25-26, 26-27, 27-28, 28-29, 29-30, 30-31, 31-32, 32-33,33-34, 34-35, 35-36, 36-37, 37-38, 38-39, 39-40, 40-41, 41-42, 42-43,43-44, 44-45 degrees, angles between the foregoing, etc.). In otherembodiments, such an angle is greater than 45 degrees (e.g., 45-50,50-55, 55-60 degrees, angles between the foregoing ranges, more than 60degrees, etc.), as desired or required. The angles of the expandedcutters relative to a longitudinal axis of the tool discussed above canapply to any wedge creation tool embodiments disclosed herein,including, without limitation, the tool 2000 illustrated in FIGS. 11A to11G.

In some embodiments, with the cutters 1024 radially expanded, the usercan rotate the tool 1000 (e.g., using the handle 1012 of the outermember 1010). Accordingly, the entire tool 1000, including the outermember 1010, the inner member 1030 and the cutting member 1020, canbegin to rotate in unison. As the tool 1000 is rotated, the radiallyexpanded cutters 1024 will begin to cut and remove the adjacent tissue(e.g., bone). With sufficient rotation of the tool 1000, areverse-tapered or wedge shaped opening can be created. In someembodiments, between 1 and 5 revolutions or rotations are required tocreate the opening. However, in other embodiments, depending on thespecific protocol or procedure, the tool 1000 can be rotated less than 1full revolution or more than 5 full revolutions. In some embodiments, asdiscussed in greater detail herein with reference to the toolillustrated FIGS. 11A to 11G, rotation of the tool (e.g., rotation ofthe outer member 1010) can be commenced prior to full expansion of thecutters 1024. In other words, the surgeon or other practitioner canbegin to rotate the tool 1000 after partial radial expansion of thecutters 1024 (e.g., when the inner member 1030 has been only partiallyadvanced within the cutting portion or member 1020 of the tool). In someembodiments, the practitioner rotates the tool 1000 at differentincrements of radial expansion of the cutters 1024. This canadvantageously facilitate the cutting or excision of bone tissue as thevolume or area of bone tissue that the cutters will need to remove willbe reduced at each incremental cutting phase (e.g., when compared toattempting to cut through a larger area of tissue at once by fullyextending the cutters 1024 in a single expansion step).

Once the desired reverse tapered or wedge shaped opening has beencreated (either via incremental radial expansion of the cutters or via asingle full expansion step for the cutters), the practitioner or otheruser can terminate rotation of the tool 1000. In some embodiments, priorto removing the tool from the opening, the user can unthread the innermember 1030 relative to the outer member 1010, thereby causing the innermember to retract from the distal end of the inner member and the tool.As a result, the distal end of the inner member 1030 will move away fromthe interior of the cutting member 1020, and the cutters 1024 will bepermitted to retract inwardly (e.g., as illustrated in FIG. 7B). Thus,the entire tool 1000 can be safely removed from the opening in a mannerthat will prevent further cutting by the cutters 1024. However, the tool1000 provides a safety measure in that if the surgeon or other useraccidentally removes the tool 1000 prior to retracting the inner member(e.g. when the cutters 1024 are at least partially expanded), only aportion of the anatomical area surrounding the opening will be affected.In other words, since, in some embodiments, the cutters 1024 onlypartially surround the distal end of the outer member 1010, retractionof at least partially expanded cutters 1024 will only damage theportions of the subject's anatomy through which the cutters 1024 willpass. Thus, the tool 1000 disclosed herein provides a safer manner ofcreating a wedge shaped opening.

The tool 1000 can be designed and otherwise configured to be manuallyrotated by the user (e.g., once the cutters 1024 have been radiallyexpanded). This can further enhance the safety of the tool and therelated method, as the manual rotation of the tool 1000 is less likelyto cause undesirable damage to the targeted anatomical area during use.However, in other embodiments, the tool 1000 can be mechanically coupledto a motorized device (e.g., a drill, another mechanical device, etc.)to assist in the rotation of the tool 1000, and thus, the creation ofthe opening.

The configuration of the cutting portion or member 1020, 2020 of theembodiments disclosed herein, or variations thereof, can also provideadditional benefits and advantages. In some embodiments, since thecutters 1024, 2024 only partially circumscribe or define a periphery ofthe distal cutting surface, accidental retraction of the tool while thecutters 1024, 2024 are radially expanded will reduce or minimize thedamage caused to the native tissue of the subject being treated. Forinstance, if the practitioner inadvertently withdraws the tool 1000,2000 while the cutters 1024, 2024 are radially expanded, the damageincurred to the subject's bone tissue will likely be limited to theregions through which the cutters 1024, 2024 pass. In other words, withrespect to the cutting members 1020, 2020 disclosed herein, under suchaccidental circumstances, the cutters 1024, 2024 will move and cutthrough, and thus at least partially damage, the bone tissue along onlytwo sides of the opening. This is in contrast to cutting tools thatinclude circumferential cutters (e.g., cutters that extend along anentire periphery or nearly an entire periphery) of the device.Retraction of such tools having a larger cutter footprint will severelydamage the entire bone region being treated and will likely render sucha region incapable of implantation of an implant.

According to some embodiments, as noted herein, the wedge-creation tool1000, 2000 can be configured to be reusable. In other words, the toolcan be designed for sterilization and/or other cleaning proceduresbetween uses or between patients. This can help reduce material costsand can provide one or more additional benefits and advantages. Forexample, reusing the tool can lower costs to the practitioner or otheruser or owner. In addition, reuse of the tool can help eliminate waste,thereby providing environmental benefits. However, in other embodiments,as discussed in greater detail herein, one or more components orportions of the tool 1000, 2000 can be disclosable, as desired orrequired. In fact, in one embodiment, the entire tool can be configuredfor disposal and replacement after a single use, as desired or required.

FIGS. 11A-11G illustrates various views of another embodiment of awedge-creation tool 2000 that is similar to other configurationsdiscussed above (e.g., the tool 1000 of FIGS. 7A-10C). As shown in theperspective views of FIGS. 11A and 11B, the tool 2000 can include anouter member 2010 having a two-part construction or design. For example,the outer member 2010 can comprise a proximal portion or section 2011Athat is configured to removably couple to a distal portion or section2011B. As best illustrated in the exploded perspective view of FIG. 11D,the proximal and distal portions or sections 2011A, 2011B of the outermember 2010 can be coupled to each other using a threaded connection.However, in other embodiments, any other type of connection feature ormethod can be used to removably attach the two portions or sections2011A, 2011B of the outer member 2010 to one another, such as, forexample, friction fit or press fit connections, a flanged connection, asnap fit connection, one or more other types of mechanical connectionsand/or the like. Further, in some embodiments, the outer member 2010 caninclude three or more different sections or portions, as desired orrequired.

With continued reference to FIGS. 11A and 11B, the tool 2000 can includeall or some of the features and components discussed herein in relationto the tool 1000 illustrated in FIGS. 7A to 10C. Such features andcomponents include, without limitation, an inner member 2030 and acutting member or portion 2020. In some embodiments, the inner member2030 is sized, shaped and configured to threadably engage an interior ofthe outer member 2010. For instance, as shown in the explodedperspective view of FIG. 11D, the inner member 2030 includes anon-threaded distal shaft 2036 and a threaded portion 2034 that isproximal to the distal shaft 2036. The inner member 2030 can bepositioned within a proximal opening of the outer member 2010 (e.g., theproximal portion 2011A of the outer member) and rotated relative to theouter member 2010 so that the threaded portion 2034 of the inner member2030 engages a corresponding threaded portion along the proximalinterior of the outer member 2010.

As discussed herein, once the tool 2000 is fully assembled with thecutting member or portion 2020 secured to the outer member 2010, thecontinued advancement (e.g., in the distal direction) of the innermember 2030 relative to the interior of the outer member 2010 will movethe distal shaft 2036 of the inner member within an interior opening orregion of the cutting member or portion 2020. This can cause the cutters2024 of the cutting member or portion 2020 to radially expand (e.g., soas to create a wedge or reverse tapered shape). Once the cutters 2024 ofthe cutting member or portion 2020 have been partially or fully radiallyexpanded, rotation of the entire tool 2000 (e.g., via manipulation ofthe proximal handle 2012 of the outer member 2010) can cause the cutters2024 to remove bone and other native tissue of the subject along thetargeted anatomical site (e.g., a joint) to transform a cylindricalopening or cavity into one that has a wedge shape.

The embodiment of FIGS. 11A-11G is different from the one illustrated inFIGS. 7A to 10C in regard to the manner in which the cutting member orportion 2020 is retained relative to the outer member 2010. As shown inFIG. 11D, the cutting member 2020 can include proximal tabs or otherprotrusions 2028 that extend laterally or radially outwardly. In thedepicted arrangement, the cutting member 2020 comprises two proximaltabs or protrusions 2028; however, in other embodiments, fewer (e.g., 1)or more (e.g., 3, 4, 5, 6, more than 6) tabs or protrusions 2028 can beincluded in the cutting member 2020. Further, the location, orientation,shape, length and/or any other details of the tabs or other protrusions2028 of the cutting member 2020 can vary, as desired or required.

With continued reference to FIG. 11D, in some embodiments, the distalportion or section 2011B of the outer member 2010 can include slots oropenings 2013 that are shaped, sized and otherwise configured to receivethe tabs or protrusions 2028 of the cutting member 2020. Thus, as partof the assembly of the tool 2000 (e.g., after a sterilization procedureand before use), the cutting member 2020 can be inserted within thedistal portion 2011B of the outer member 2010 so that the tabs orprotrusions 2028 of the cutting member 2020 align with and are able toslide relative to the slots or openings 2013 of the distal portion 2011Bof the outer member 2010. After the cutting member 2020 has beenproperly positioned relative to and advanced within the distal portion2011B of the outer member 2010, the proximal portion 2011A of the outermember can be threaded onto or otherwise coupled to the distal portion2011B. This action can ensure that the cutting member or portion 2020 isproperly and securely positioned relative to the outer member 2010. Inaddition, such a design advantageously permits the cutting member 2020to be easily removed and reinserted relative to the outer member 2010for cleaning, sterilization, replacement, etc.

As discussed herein, once the cutting member or portion 2020 has beensecured relative to the outer member 2010 and the proximal end 2019 ofthe outer member 2010 has been positioned within a targeted cylindricalopening of the subject's bone or other targeted site, the practitionercan begin advancing the inner member 2030 within and relative to theouter member 2010. Eventually, once the inner member 2030 has been movedsufficiently far relative to the outer member 2010, the distal shaft2036 of the inner member 2030 will move within the cutting member 2020.This causes the cutters 2024 of the cutting member 2020 to be urgedoutwardly. Given the sloped or curved nature of the interior surfaces ofthe cutters 2024, the cutters 2024 are expanded so as to create a wedgeor reverse tapered shape. Accordingly, once the cutters 2024 have beenexpanded, the practitioner can rotate the entire tool 2000 (e.g., viamanipulation of the proximal handle 2012 of the outer member 2010) tomore the expanded cutters 2024 relative to adjacent bone and/or othertissue of the subject, thereby causing bone and/or other tissue to beexcised and/or otherwise removed. As discussed herein, this canadvantageously transform the targeted cylindrical opening or cavity intoone that has the desired wedge or reverse tapered shape.

As discussed herein in reference to other embodiments, thewedge-creation tools 1000, 2000 can be configured to be used manually,without the assistance of any motorized or other power-assisted devices(e.g., electromechanical devices, pneumatic devices, etc.). This canhelp ensure that the wedge shape is created in a safe and predictablemanner. Also, such embodiments can help avoid any inadvertent damage(e.g., irreversible damage) to a targeted bone or other portion of theanatomy being treated. For example, the use of motorized drills or otherpower-assisted (e.g., non-manual) tools to create such wedge-shapedopenings can lead to extensive damage to the targeted bone, and thus, tothe inability to properly treat such an area with an implant.

As discussed herein, when the inner member 2030 is advanced within theinterior of the cutting portion or member 2020, the cutters 2024 of thecutting portion or member can be radially expanded. In some embodiments,the cutters 2024 are radially expanded such that their outer diameter orother cross-sectional dimension after full expansion is 30% to 70%(e.g., 30-35, 35-40, 40-45, 45-50, 50-55, 55-60, 60-65, 65-70%,percentages between the foregoing, etc.) greater than their outerdiameter or other cross-sectional dimension when retracted. Due to thesloped inner surfaces of the cutters 2024, once fully radially expanded,the cutters 2024 will be angled relative to the longitudinal axis of thetool and relative to the walls of the cylindrical opening. In someembodiments, the angle of the expanded cutters 2024 relative to thelongitudinal axis of the cutting portion or member 2020 (and thus, theentire tool 2000) is between 0 and 45 degrees (e.g., 0-1, 1-2, 2-3, 3-4,4-5, 5-6, 6-7, 7-8, 8-9, 9-10, 10-11, 11-12, 12-13, 13-14, 14-15, 15-16,16-17, 17-18, 18-19, 19-20, 20-21, 21-22, 22-23, 23-24, 24-25, 25-26,26-27, 27-28, 28-29, 29-30, 30-31, 31-32, 32-33, 33-34, 34-35, 35-36,36-37, 37-38, 38-39, 39-40, 40-41, 41-42, 42-43, 43-44, 44-45 degrees,angles between the foregoing, etc.). In other embodiments, such an angleis greater than 45 degrees (e.g., 45-50, 50-55, 55-60 degrees, anglesbetween the foregoing ranges, more than 60 degrees, etc.), as desired orrequired.

As discussed, in some embodiments, with the cutters 2024 radiallyexpanded, the user can rotate the tool 2000 (e.g., using the handle 2012of the outer member 2010). Accordingly, the entire tool 2000, includingthe outer member 2010, the inner member 2030 and the cutting member2020, can begin to rotate in unison. As the tool 2000 is rotated, theradially expanded cutters 2024 will begin to cut and remove the adjacenttissue (e.g., bone). With sufficient rotation of the tool 2000, areverse-tapered or wedge shaped opening can be created. In someembodiments, between 1 and 5 revolutions or rotations are required tocreate the opening. However, in other embodiments, depending on thespecific protocol or procedure, the tool 2000 can be rotated less than 1full revolution or more than 5 full revolutions. In some embodiments,rotation of the tool (e.g., rotation of the outer member 2010) can becommenced prior to full radial expansion of the cutters 2024. In otherwords, the surgeon or other practitioner can begin to rotate the tool2000 after partial radial expansion of the cutters 2024 (e.g., when theinner member 2030 has been only partially advanced within the cuttingportion or member 2020 of the tool). In some embodiments, thepractitioner rotates the tool 2000 at different increments of radialexpansion of the cutters 2024. This can advantageously facilitate thecutting or excision of bone tissue as the volume or area of bone tissuethat the cutters will need to remove will be reduced at each incrementalcutting phase (e.g., when compared to attempting to cut through a largerarea of tissue at once by fully extending the cutters 2024 in a singleexpansion step). In some embodiments, a practitioner can use 2, 3, 4, 5or more than 5 increments (e.g., of varying radial expansion of thecutters 2024) during a single wedge-creation procedure.

With continued reference to FIGS. 11A-11G, the distal end 2019 of theouter member 2010 of the tool 2000 can have a tapered, cylindricalshape. The size and shape of the distal end 2019 can be selected tomatch (e.g., in diameter, depth, etc.) the cylindrical opening intowhich the distal end 2019 will be inserted. As shown, a step or similarfeature having a abutment surface can be included proximally to thedistal end along the exterior of the outer member 2010 to ensure thatthe tool 2000 cannot be advanced deeper into the targeted bone or othertissue being treated.

As shown, the distal end 2019 of the outer member 2010 can includeopenings through which the cutters 2024 of the cutting member or portion2020 pass once radially expanded. However, the distal end 2019 of theouter member 2010 can also include additional recesses, openings orslots 2015 that are separate and aside from the openings configured toaccommodate the expanded cutters. Such additional slots 2015 canfacilitate the accommodation and/or removal of excised bone and/or othertissue during the course of a procedure.

In some embodiments, the inner member 2030 is cannulated or otherwiseincludes one or more openings (e.g., along its longitudinal or axialcenterline). As shown in the longitudinal, cross-sectional view of FIG.11E, a central opening 2036 of the inner member 2030 can extend alongthe entire length of the inner member 2030, including the proximalhandle 2035. Such an opening 2036 can permit the tool 2000 to be placedover a guide pin or other guiding tool to help assist with the accuratepositioning of the tool, and thus the creation of a reverse-tapered orwedge opening, during use.

In some embodiments, such an opening 2036 can also be helpful inremoving excised bone tissue that has been cut during a procedure. Forexample, in some embodiments, a rod or other device can be insertedwithin the opening 2036 to push bone material distally (e.g., out thedistal end of the outer member and the entire tool). In otherembodiments, a vacuum or suction force can be applied to the opening2036 to selectively pull out excised bone and/or other tissue. Suchprocedure can be performed during, before or after a cutting procedure,as desired or required. In some embodiments, one or more liquids and/orother fluids (e.g., water, saline, medicaments, etc.) can becontinuously or intermittently provided through the opening 2036 duringuse so as to reach the bone site being treated. Such fluids can assistin executing a particular protocol (e.g., to provide a desired degree ofmoisture or lubrication to facilitate the cutting process and/or themovement of the device during use, etc.).

As discussed above, any of the tool embodiments disclosed herein can bemade to be disposable (e.g., single-use) items or reusable items. Insome embodiments, one or more of the components of the tool can bereusable (e.g., the inner and outer members), whereas one or more of thecomponents of the tool can be disposable (e.g., the cutting member orportion), as desired or required. A reusable tool (or the reusablecomponents of a hybrid tool) can comprise one or more metals or alloys(e.g., stainless steel), thermoplastics and/or the like. In someembodiments, such reusable components are configured to be sterilizedbetween uses or subjects being treated. In some embodiments, thesterilization of reusable tools or components thereof includes exposureto one or more chemical solutions or materials, autoclaving (e.g., withthe requisite time exposure and requisite temperature) and/or any othersterilization or cleaning technique.

Once a reverse taper implant site has been created in the targeted jointor other portion of the patient (and, where applicable, the guide pin orother member has been removed), a clinician can deliver the implant tothe implant site using an introducer 600. As illustrated in FIGS.12A-13B, an introducer 600 can include a generally cylindricalintroducer tube 610 having an opening 620 through which the implant maybe passed. In some embodiments, the distal end 606 of the introducertube 610 can comprise a neck or other narrowed portion 608. As shown inFIG. 13B, the neck portion 608 can include a wall 612 having a roundeddistal edge 613. In some embodiments, the neck portion 608 has a length(labeled 614 in FIG. 12C) of about 0.155 inches to about 0.170 inches.Further, as best illustrated in the longitudinal cross-sectional view ofFIG. 12C, the internal diameter of the introducer tube 610 can varyalong its length. For example, in the depicted embodiment, a proximalportion 618 of the introducer 600 comprises a flared shape, wherein theinside diameter of the opening 620 is progressively reduced in theproximal to distal direction. Further, as shown, the opening 620 canmaintain a generally constant inner diameter along a second, more distalportion 616 of the introducer tube 610. In other embodiments, the innerdiameter, length, other dimension and/or other details or properties ofthe introducer 600, including its flared interior portion 628, itsgenerally cylindrical interior portion 626 of the introducer tube 610,its neck portion 608 and/or the like can be different than shown inFIGS. 12A-12C and 13A-13B and described herein. By way of example, theembodiment illustrated in FIG. 14A comprises a longer flared interiorportion 728 (e.g., relative to the adjacent generally cylindricalportion 726) than the introducer 600 of FIG. 12C.

Another embodiment of an introducer 700 a is illustrated in FIG. 14B. Asshown, the introducer 700 a can include the tapered interior surfacealong the distal end 726 a (e.g., as opposed to the proximal end, asdepicted in other arrangements herein). This can facilitate theinsertion within and/or passage through the interior of the introducer700 a since the implant advanced therethrough will not be radiallycompressed until the distal portion 726 a of the introducer. Thus, insome embodiments, the proximal portion 728 a of the interior of theintroducer 700 a can be cylindrical (e.g., non-tapered), which thedistal portion 726 a of the interior of the introducer can be tapered(e.g., sloped, flared, etc.). Such a design can be incorporated into anyof the embodiments of an introducer disclosed herein or equivalentsthereof.

In some embodiments, as illustrated in FIG. 14B, the introducer cancomprise a two-part or multi-part construction, as desired or required.For example, in some embodiments, the distal end of the introducer 700 aincludes an insert 712 a comprising a metal and/or alloy (e.g.,stainless steel), whereas the proximal portion 710 a of the introducercomprises a different material, such as, for example, a polymericmaterial (e.g., polycarbonate). Such a configuration can help create alower cost introducer 700 a, and thus, implant insertion system or kit.Further, the stronger (e.g., more rigid) distal insert 712 a can helpmaintain its shape to facilitate resisting the higher compressive forces(e.g., generated by the compressed implant passing therethrough) and/orto permit for a thinner wall distal end 714 a of the introducer. In someembodiments, the introducer 700 a and/or any other component or theimplant delivery system can be disposable and/or reusable, as desired orrequired.

The neck portion 608 of the introducer tube 610 can be positioned atleast partially within the opening or recess into which the implant willbe secured. In some embodiments, the introducer can be sized, shaped andotherwise configured to that the neck portion 608 fits generally snuglywithin the implant site. With reference to FIGS. 15A-15C, an implant 10can be placed within the opening 628 along the proximal end 602 of theintroducer 600. As shown, in some embodiments, the implant 10 isadvanced into the interior of the introducer 600 with its base or bottom14 end first.

As the implant 10 is urged deeper (e.g., more distally) into theinterior of the introducer 600, the implant 10 may become radiallycompressed by the adjacent interior walls. If sufficient force isapplied to the implant 10, the implant 10 passes through the neckportion 608 of the introducer and into the implant site R. Asillustrated in FIG. 15C, in such an arrangement, the implant's base end14 will be located along the bottom of the implant site. According tosome embodiments, a plunger or other pusher member (not shown) can beinserted within the interior of the introducer to help push the implantthrough the introducer and into the implant site. Such a plunger orpusher member can be operated manually and/or with the assistance of anexternal power-assist device (e.g., mechanically, pneumatically,hydraulically, etc.), as desired or required.

According to some embodiments, once a reverse taper site has beencreated in the targeted joint or other portion of the patient (and,where applicable, the guide pin or other member has been removed), aclinician can deliver the implant to the implant site using amechanically-assisted delivery tool or introducer 800. One embodiment ofsuch a tool is illustrated in FIGS. 16A-16C. Another embodiment of sucha tool is illustrated in FIGS. 16D-16E. As shown, the delivery tool orintroducer 800 can comprise, among other things, an introducer tube 810,a plunger 820, a handle 830 and a clamp 840.

Such mechanically-assisted delivery devices can be helpful in advancingthe implant through the interior of an introducer tube against arelatively large resistance of back-pressure. Such a resistive force canbe particularly high when the implant comprises a relatively large taperangle θ. Accordingly, in some embodiments, the use of such deliverytools makes the delivery of reverse taper implants into correspondingimplant sites possible, while allowing the clinician to safely andaccurately guide the implant into a targeted anatomical implant site. Inseveral embodiments, the delivery tool is capable of overcomingresistive forces of about 5 to about 20 pounds. In some embodiments, thedelivery tool exerts a force about 5 to about 25. In some embodiments,the delivery device is operated by or with the assistance of one or moremotors. For example, in some embodiments, the clamp is moved (e.g.,rotated) relative to the handle using (or with the assistance of) one ormore stepper motors and/or any other type of motor or actuator. In someembodiments, delivery of an implant through the introducer tube 810 isaccomplished with at least some assistance from air or pneumaticpressure. For example, air or other fluid can be injected into theinterior of the introducer tube once the implant is inserted therein.The delivery of air can be incorporated into a plunger member 820 (e.g.,via one or more interior lumens) so that the implant can be advancedthrough the introducer tube 810 into the implant site using mechanicalforce (e.g., by moving the plunger 820 through the tube 810) and/or byinjecting air and/or other fluids into the interior of the tube 810. Thefluid openings through the plunger 820 and/or any other fluid passagescan be placed in fluid communication with a compressor or other fluidgenerating device. Advancement of the implant through the introducertube 810 can be accomplished by applying a vacuum along or near thedistal end of the tube 810 (e.g., through one or more vacuum ports alongthe introducer tube 810). Such vacuum ports or openings can be placed influid communication with a vacuum or other suction generating device.

According to some embodiments, the delivery tool comprises one or moredepth stop features or components to ensure that the implant beingdelivered to a target implant site is properly delivered into the targetimplant site. In some embodiments, the depth stop features help protectthe structural integrity of the implant as the implant is being insertedwithin the target anatomical implant site.

In some embodiments, the delivery device comprises and/or is operativelycoupled to one or more pressure gauges or other pressure or forcemeasuring devices, members or features. Such gauges or other measurementdevices can help ensure that a maximum backpressure or force is notexceeded when operating the device. This can help protect the integrityof the implant (e.g., to ensure that the structural integrity, watercomposition and/or other properties of the implant are maintained),protect the delivery device, protect the user and/or the patient and/orprovide one or more other advantages or benefits.

According to some embodiments, the introducer tube 810 of the deliverytool or device 800 comprises one or more viewing windows that permit theimplant to be viewed as it is being advanced through the device 800 tothe implant site. In some embodiments, the introducer tube 800 (and thusthe longitudinal axis along which the implant is advanced through thedelivery tool or device) is substantially perpendicular with the surfaceof the bone or other anatomical site into which the implant will bedelivered and/or the handle 830 of the device 800.

According to some embodiments, at least a portion of the interior of theintroducer tube 810 comprises and/or is otherwise coated or lined withone or more absorbable or lubricious layers, materials and/or othersubstances. Such materials can help preserve the moisture level of theimplant as it is being advanced through the introducer tube 810. Theinterior surface of the introducer tube can comprise a low coefficientof friction to facilitate the delivery of an implant through thedelivery device or tool 800. In some embodiments, the effectivecoefficient of friction along the interior of the introducer tube can belowered polishing such surfaces. As noted herein, the introducer,including its interior surfaces, can comprise surgical grade stainlesssteel.

According to some embodiments, the delivery tool or device 800 isincorporated into the tool configured to create a reverse taperedimplant site. For example, such a combination device can be coupled to adrill or other mechanical device to first create the implant site. Then,the combination device can take advantage of the mechanical outputgenerated by the drill and/or other mechanical or motorized device tohelp urge the implant through the introducer tube of the combinationdevice.

As illustrated in FIGS. 17A and 17B, the introducer tube 810 of themechanically-assisted delivery tool 800 can be hollow and generallycylindrical in shape. However, in other embodiments, the shape, generalstructure and/or other characteristics of the tube 810 can be differentthan disclosed herein. In some embodiments, the introducer tube 810comprises an externally threaded portion 814, a proximal portion 812extending between a proximal end 802 and the externally threaded portion814, and a distal portion 816 extending between the externally threadedportion 814 and a distal end 804. The distal end 804 of the introducer810 can comprise a neck or other narrowed portion 806.

As best illustrated in the longitudinal cross-sectional view of FIG.17B, the internal diameter of the introducer tube 810 can vary along atleast a portion of the tube's length. For example, in the depictedembodiment, the proximal portion 812 of the introducer or introducertube 810 has a generally constant, consistent or flat inner diameter. Inaddition, as shown, the distal portion 816 of the introducer tube 810can comprise a generally tapered or sloped portion 816 a, such that theinside diameter of the tube is progressively reduced in the proximal todistal direction. In some embodiments, the slope along the interiorsurface of the tube 810 can be generally linear. However, in otherarrangements, the slope of the interior surface of the tube 810 is atleast partially non-linear (e.g., curved, rounded, irregular, etc.),either in addition to or in lieu of any generally linear and/or constantportions, as desired or required for a particular application or use.Further, in some embodiments, as illustrated in the cross-sectional viewof FIG. 17B, a portion 816 b proximate the distal end 804 comprises agenerally constant or flat (e.g., non-sloped) inner surface or diameter.Further, in other embodiments, the inner diameter or surface, length,other dimensions and/or other details or properties of the introducertube 810, including any internal tapered or sloped portions 816 a, anygenerally cylindrical (e.g., constant, flat, non-sloped, etc.) interiorportions 816 b, any neck portions 806 and/or the like can be differentthan shown in FIGS. 17A-17B and described herein.

According to some embodiments, the proximal portion 812 of theintroducer tube 810 includes one or more slits or other openings 818. Asshown, such a slit 818 can begin adjacent to or near the externallythreaded portion 814 of the tube 810 and can extend to or near theproximal end 802 of the tube 810. In some embodiments, the proximalportion 812 of the introducer tube includes two (or more) slits 818located opposite each other in the introducer 810 to form a channelthrough the proximal portion 812. In some embodiments, for example asshown in FIGS. 16D-16E, the proximal portion 812 of the introducer tube810 comprises a flange 819 or other protruding or flared portionextending outwardly (e.g., radially outwardly in a continuous orintermittent manner) from or near the proximal end 802. In otherembodiments, the flange or other protruding member 819 can be locatedalong one or more other longitudinal locations of the tube 810, asdesired or required. The flange 819 can be substantially or generallyflat and/or can include any other shape (e.g., curved, fluted, etc.).The flange 819 can be integrally formed or attached to the proximalportion 812 of the tube 810. Alternatively, the flange 819 can be aseparate member that can be selectively attached to or removed from thetube 810 and/or any other portion of the tool 800.

With reference to FIG. 18, the plunger 820 of the tool 800 can begenerally cylindrical in shape with an enlarged proximal head portion822 that includes a domed proximal end 824. In some embodiments, in aproperly assembled mechanically-assisted delivery tool 800, the plunger820 is shaped, sized and otherwise configured to slide within the hollowinterior passage of the introducer tube 810. Thus, as discussed ingreater detail herein, by actuating the tool, a clinician or other usercan selectively move the plunger within an interior portion of theintroducer tube 810 in order to urge an implant (e.g., a taperedimplant) through the distal end of the tube and into a targeted implantsite of a patient.

With continued reference to FIG. 18, the main body 826 of the plunger820 can have a diameter approximately the same as and/or slightlysmaller than the inner diameter of the neck portion 806 and distalportion 816 b of the introducer 810. In some embodiments, as illustratedin the embodiment of FIG. 16E, the head portion 822 of the plunger 820includes a motion limiter or depth stop 828. The motion limiter 828 cancomprise one or more knobs, protrusion members and/or other members orfeatures that generally extend outwardly from the head portion 822 ofthe plunger. In some embodiments, such a motion limiter, depth stopmember or feature and/or other protruding member 828 is configured toslide within the slit(s) 818 or other openings of the introducer tube810. These features can help prevent or otherwise limit distal movementof the plunger 820 relative to the introducer tube (e.g., when themotion limiter or depth stop 828 contacts or abuts the base of theslit(s) 818). Further, such a feature can help prevent or limit rotationof the plunger relative to the tube 810 during use. In some embodiments,the head portion 822 of the plunger 820 comprises a diameterapproximately the same as and/or slightly smaller than the innerdiameter of the proximal portion 812 of the introducer tube 810.Accordingly, movement of the plunger 820 relative to the tube 810,beyond a particular point, will generally be prevented or limited whenthe head portion 822 contacts or abuts the narrowing inner diameter ofthe tapered portion 816 a of the distal portion 816 of the introducertube. Therefore, the corresponding abutting features of the plunger 820and the introducer tube 810 can advantageously help limit the depth towhich an implant (e.g., tapered implant) can be delivered relative to animplant site of a patient. In some embodiments, this can help improvethe safety and efficacy of the implant, the related tools and theimplant procedure.

According to some embodiments, as illustrated in FIG. 19A, the handle830 of the delivery tool 800 comprises a generally circular internallythreaded nut portion or introducer tube receiving portion 834. As shown,the threaded nut portion or introducer tube receiving portion 834 can beinterposed between an elongate proximal section 832 and an elongatedistal section 836. In the depicted arrangement, the introducer tubereceiving portion 834 is located closer to the distal section 836 of thehandle 830. However, in other embodiments, the portion 834 can belocated along any other portion of the handle 830, as desired orrequired. Further, the introducer tube receiving portion 834 can includeone or more other engagement or connection features or devices (e.g.,snap connections, press-fit or friction-fit connections, screws or otherfasteners, adhesives, etc.), either in lieu of or in addition to athreaded connection.

With continued reference to the perspective view of the handleillustrated in FIG. 19A, the proximal portion or section 832 of thehandle can be longer than the distal portion or section 836. In otherwords, as noted above, the introducer tube receiving portion 834 can bepositioned closer to the distal end than the proximal end of the handle830. However, in other embodiments, the introducer tube receivingportion 834 is located at or near between the distal and proximal endsof the handle, or at, near or closer to the proximal end of the handle,as desired or required.

As shown in FIG. 19A, the proximal section 832 and distal section 836can extend in generally opposite directions from the nut or introducertube receiving portion 834. However, in some embodiments, a longitudinalaxis of the distal section 836 is slightly offset from a longitudinalaxis of the proximal section 832. Such a configuration can assist withthe coupling of the clamp 840 as described herein. For example, in theillustrated embodiment (e.g., when viewed from the top as shown in FIG.19B), a centerline or orientation of the distal section or portion 836of the handle is generally offset with respect to the centerline ororientation of the proximal section 832. The introducer tube receivingportion 834 can be sized, shaped and otherwise configured so that thedistal section 816 of the introducer tube 810 can pass through theopening of the introducer receiving portion 834. Further, the externallythreaded portion 814 of the introducer tube 810 can operatively engageand mate with the internal threaded portion of the introducer tubereceiving portion 834. As noted above, in other embodiments, the handle830 can engage the introducer tube 810 using one or more otherattachment methods, features or devices (e.g., fasteners, snap-fit orfriction-fit connections, other mating connections or couplings,adhesives, etc.) either in addition to or in lieu of a threadedconnection.

In some embodiments, the elongate proximal section or portion 832 of thehandle comprises a grasping portion 838 configured to be selectivelygripped and manipulated by a user during use. The grasping portion 838can be contoured, shaped and/or otherwise configured to improve theuser's grip on the handle 830. In the illustrated embodiment, the distalsection or portion 836 of the handle comprises a generally rectangularcross-section. However, the distal portion and/or any other portion ofthe handle 830 can include any other shape (e.g., circular, oval,square, polygonal, etc.). When the nut portion of introducer receivingportion 834 is oriented horizontally, the distal section 836 of thehandle comprises a generally vertical shape so that it is taller than itis deep.

According to some embodiments, the distal section 836 of the handle 830comprises a keyhole 837 or other opening for coupling to the clamp 840of the device. The keyhole 837 or other opening can be configured toallow the clamp 840 to be quickly and easily connected to and/ordisconnected from the handle 830. In other arrangements, however, theclamp 840 can be permanently or substantially permanently attached tothe handle 830. In other embodiments, the size, shape, orientation,and/or other details or properties of the handle 830 can be differentthan shown in FIGS. 19A-19B and described herein.

With reference to FIGS. 20A and 20B, the clamp 840 can comprise anelongate member having a slight curve. A proximal portion of the clamp840 can include a handle or grasping portion 848 that a user can gripduring use of the device. A distal portion 846 of the clamp 840 isgenerally sized, shaped and otherwise configured such that it can bemoved within the slit 818 of the introducer tube 810. In someembodiments, as illustrated herein, the distal end of the clamp 840comprises a key 847 for insertion within the keyhole or other opening837 of the handle 830 in order to couple the clamp to the handle.

Therefore, the handle 830 and the clamp 840 can be connected to oneanother about a hinge or other rotatable point, thereby permitting thehandle to be selectively rotated and/or otherwise moved relative to theclamp. As discussed in greater detail herein, such a relative rotationbetween the clamp and the handle can be used to provide the mechanicalforce necessary to move the plunger 820 within the introducer tube 810.This can advantageously urge an implant (e.g., tapered hydrogel implant)through the tube 810 and into a target recess of an implant site.Accordingly, the forces created by moving the clamp relative to thehandle can help move an implant against relatively high back-forces(e.g., against relatively high friction and/or other resistive forces)within the introducer tube. Such movement of the implant can beparticularly difficult for reverse tapered implants where at least aportion of such implants experiences generally high radially compressiveforces while being moved through an interior lumen or other opening ofthe introducer tube 810.

According to some embodiments, to assemble the delivery device 800 inpreparation for use, the user inserts the implant 10 (e.g., reversetapered implant, other joint implant, etc.) into the introducer tube 810via the proximal end 802. The plunger 820 can then be inserted into theproximal end 802 of the introducer tube 810 and used to distally advancethe implant 10 within the introducer tube 810. Once the handle 830 iscoupled to the introducer tube 810 (e.g., by threading the nut portionor introducer tube receiving portion 834 onto the externally threadedportion 814 of the introducer tube 810), the clamp 840 can be coupled tothe handle 830 by inserting the key 847 (or other protruding portion orfeature) of the clamp 840 into the keyhole 837 (or other opening) of thehandle 830. When assembled, e.g., as illustrated in FIGS. 16A, 16C, 16Dand 21A-21C, the clamp 840 is generally positioned and movable withinthe slit 818 of the introducer tube 810.

As discussed in greater detail herein, the clamp 840 can be rotatablyattached to the handle 830 (e.g., at a hinge point), thereby allowing auser to selectively rotate or otherwise move the clamp relative to thehandle (e.g., to move the clamp 840 toward or away from the handle 830within the slit, groove or other opening of the introducer tube 810). Insome embodiments, an offset between the distal section 836 and proximalsection 832 of the handle 830 permits the distal portion 846 of theclamp 840 to be aligned with the slit 818 in the introducer tube so thatthe clamp can be selectively moved within the slit 818 when the clamp840 and handle 830 are coupled to one another (e.g., via the key847-keyhole 837 joint or a similar feature or mechanism). Therefore, insome embodiments, the delivery device 800 is configured for quick, easyand convenient assembly and disassembly for cleaning, sterilization,repair, maintenance and/or any other reason or purpose.

According to some embodiments, the various components of themechanically-assisted delivery device 800 comprise one or more rigidand/or semi-rigid materials that are configured to withstand the forces,moments, chemicals and/or other substances, temperature fluctuationsand/or other elements to which they may be exposed. For example, thecomponents of the implant delivery device can comprise one or moremetals (e.g., stainless steel, other surgical steel, other types ofsteel, etc.), alloys, plastics and/or the like. Such materials canpermit the device to be autoclaved, sterilized or otherwise cleanedduring a specific disinfection protocol. In addition, the structural andother physical characteristics of the device can permit the user toexert the necessary forces using the device to deliver implants ofvarious sizes, shapes and/or configurations through the correspondingintroducer tube and into a target implant site of a patient.

In use, the distal neck portion 806 of the introducer tube 810 can bepositioned at least partially within the opening, recess or otherimplant site into which the implant 10 will be secured. In someembodiments, the introducer tube 810 is sized, shaped and otherwiseconfigured to that the neck portion 806 fits generally snugly within theimplant site. To deliver the implant 10 (e.g., reverse taper implant)through the device 800 and into the targeted implant site, the user canurge the clamp 840 toward the handle 830 of the device (e.g., so thatthe clamp rotates or otherwise moves relative to the handle). Accordingto some embodiments, as the distal portion 846 of the clamp 840 movesdownwardly through the slit, slot or other opening 818 of the introducertube 810, a portion of the clamp 840 (e.g., the distal portion 846)contacts the plunger 820 (e.g., the domed proximal end 824), and urgesthe plunger 820 distally within the introducer tube 810.

As illustrated in FIGS. 21A-21C, such a movement, in turn, urges theimplant 10 distally within the introducer tube 810. As the implant 10 isurged deeper (e.g., more distally) into the interior of the introducertube 810, the implant 10 may become radially compressed by the interiorshape (e.g., tapered portion 816 a) of the introducer tube 810. Ifsufficient force is applied to the implant 10 by moving the clamprelative to the handle, the implant 10 can pass through the neck portion806 of the introducer tube and into the implant site. In someembodiments, the motion limiter 828 or similar feature of the plunger820 can contact the distal end of the slit or similar opening 818 of theintroducer tube 810 when the implant 10 has been released from thedelivery device 800 into the implant site. As depicted in FIG. 21C, thiscan help prevent the plunger 820 from continuing to move toward and intothe implant site and possibly damaging the implant site and/or theimplant 10. While the user grasps the handle 830 and the clamp 840 withone hand, he or she can apply a required force on the flange 819 thatextends outwardly from the proximal end 802 of the introducer tube 810with the other hand to stabilize and control the introducer 810.

Accordingly, the mechanically-assisted delivery devices disclosedherein, or equivalents thereof, can facilitate the compression anddelivery of reverse tapered implants within a target implant site. Insome embodiments, the mechanically-assisted delivery device can beconfigured to be operated at least partially with the assistance of amechanical motor, a pneumatic device and/or another external device. Forexample, the clamp of the device can be moved relative to the handle byor with the assistance of one or more motors (e.g., regulated by a userusing a button, knob, dial and/or other controller). Such embodimentscan further facilitate the delivery of implants within an implant siteof a patient.

In several embodiments, a kit is provided. The kit may include one ormore tools for creating a wedge shaped opening or recess, one or moreintroducers and/or one or more implants. Two, three or more tools may beprovided, alone or in combination with two, three or more implants(and/or corresponding introducers). Multiple tools and implants may beprovided in a kit to provide flexibility in sizes and shapes.

Although several embodiments and examples are disclosed herein, thepresent application extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of the variousinventions and modifications, and/or equivalents thereof. It is alsocontemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments may be made and stillfall within the scope of the inventions. Accordingly, various featuresand aspects of the disclosed embodiments can be combined with orsubstituted for one another in order to form varying modes of thedisclosed inventions. Thus, the scope of the various inventionsdisclosed herein should not be limited by any particular embodimentsdescribed above. While the embodiments disclosed herein are susceptibleto various modifications, and alternative forms, specific examplesthereof have been shown in the drawings and are described in detailherein. However, the inventions of the present application are notlimited to the particular forms or methods disclosed, but, to thecontrary, cover all modifications, equivalents, and alternatives fallingwithin the spirit and scope of the various embodiments described and theappended claims. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element and/or the like in connection with an implementation orembodiment can be used in all other implementations or embodiments setforth herein.

In any methods disclosed herein, the acts or operations can be performedin any suitable sequence and are not necessarily limited to anyparticular disclosed sequence and not be performed in the order recited.Various operations can be described as multiple discrete operations inturn, in a manner that can be helpful in understanding certainembodiments; however, the order of description should not be construedto imply that these operations are order dependent. Additionally, anystructures described herein can be embodied as integrated components oras separate components. For purposes of comparing various embodiments,certain aspects and advantages of these embodiments are described. Notnecessarily all such aspects or advantages are achieved by anyparticular embodiment. Thus, for example, embodiments can be carried outin a manner that achieves or optimizes one advantage or group ofadvantages without necessarily achieving other advantages or groups ofadvantages.

The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “creating a recess or opening” or “delivering animplant” include “instructing crating a recess or opening” or“instructing delivering an implant,” respectively. The ranges disclosedherein also encompass any and all overlap, sub-ranges, and combinationsthereof. Language such as “up to,” “at least,” “greater than,” “lessthan,” “between,” and the like includes the number recited. Numberspreceded by a term such as “about” or “approximately” include therecited numbers and should be interpreted based on the circumstances(e.g., as accurate as reasonably possible under the circumstances, forexample ±5%, ±10%, ±15%, etc.). For example, “about 1 mm” includes “1mm.” Phrases preceded by a term such as “substantially” include therecited phrase and should be interpreted based on the circumstances(e.g., as much as reasonably possible under the circumstances). Forexample, “substantially rigid” includes “rigid,” and “substantiallyparallel” includes “parallel.”

What is claimed is:
 1. A tool for creating a wedge opening within a bonetissue, comprising: an outer member comprising a first end and a secondend, a cylindrical interior extending from the first end to the secondend and having openings at the first and second ends, the first endcomprising a tapered portion configured to be inserted within acylinder-shaped opening created within the bone tissue; a cutting membercomprising an inner passage, positioned within the cylindrical interiorof the outer member near the first end of the outer member and coupledto the outer member, the cutting member comprising at least one cutterconfigured to be radially expanded outward; and an inner memberconfigured to be moved within the inner passage of the cutting member,wherein when the inner member is moved within the inner passage of thecutting member, the at least one cutter is configured to radiallyexpand, wherein the at least one cutter is configured to radially expandat an angle relative to a longitudinal axis of the tool so as to createthe wedge opening within the bone tissue when the at least one cutter isexpanded and rotated relative to said tissue, and wherein the outermember comprises a first outer member portion and at least a secondouter member portion, wherein the first outer member portion isconfigured to couple and secure to the second outer member portion priorto use.
 2. The tool of claim 1, wherein the first outer member portionis configured to couple to the second outer member portion using athreaded connection.
 3. The tool of claim 1, wherein the cutting memberis configured to be secured relative to the outer member when the firstouter member portion is coupled to the second outer member portion. 4.The tool of claim 3, wherein the cutting member comprises at least oneprotruding member, wherein the at least one protruding member isconfigured to move within at least one corresponding slot provided inthe at least one of the first outer member portion and the second outermember portion when the first outer member portion is coupled to thesecond outer member portion.
 5. The tool of claim 1, wherein the atleast one cutter comprises a sloped inner surface, such that when theinner member is advanced within an interior of the cutting member, theinner member engages and urges the at least one cutter radiallyoutwardly.
 6. The tool of claim 1, wherein the at least one cutter isconfigured to radially retract once the inner member is retracted froman interior of the cutting member.
 7. The tool of claim 1, wherein theinner member and the cutting member are cannulated, thus forming anaxial opening through the tool to permit the passage of a guide pin orother device through the axial opening.